Medical Device Resume Samples

The Guide To Resume Tailoring

Guide the recruiter to the conclusion that you are the best candidate for the medical device job. It’s actually very simple. Tailor your resume by picking relevant responsibilities from the examples below and then add your accomplishments. This way, you can position yourself in the best way to get hired.

  • Craft your perfect resume by picking job responsibilities written by professional recruiters

  • Pick from the thousands of curated job responsibilities used by the leading companies

  • Tailor your resume by selecting wording that best fits for each job you apply

MR
M Romaguera
Mack
Romaguera
68776 Conn Avenue
Phoenix
AZ
+1 (555) 357 7149
68776 Conn Avenue
Phoenix
AZ
Phone
p +1 (555) 357 7149
Experience Experience
07/2015 present
Boston, MA
Medical Device Package Manager
Boston, MA
Medical Device Package Manager
07/2015 present
Boston, MA
Medical Device Package Manager
07/2015 present
  • Responsibly manage data in Laboratory Information Management Systems (LIMS) and Laboratory Notebooks
  • Develop/improve processes in the Package Testing Lab
  • Assist in equipment qualification and development of SOPs
  • Assist in receipt/storage of customer samples
  • Performs other duties as assigned
  • Provide Medical Device packaging expertise to internal/external customers
  • Develop technical reports of test results following defined documentation procedures
12/2011 03/2015
Chicago, IL
Medical Device Operator
Chicago, IL
Medical Device Operator
12/2011 03/2015
Chicago, IL
Medical Device Operator
12/2011 03/2015
  • Working with EH & S and engineering to assure a safe work environment
  • Working with EH&S and engineering to assure a safe work environment
  • Performing data collection and entry
  • Be energized by working for a world-class manufacturer and collaborating on cross-functional teams
  • Performing data collection/computer entry
  • Working in a cleanroom manufacturing environment
  • Performing hand assembly and visual inspection
06/2009 07/2011
Boston, MA
Medical Device
Boston, MA
Medical Device
06/2009 07/2011
Boston, MA
Medical Device
06/2009 07/2011
  • Provide input to line managers of project team members' performance relative to project tasks
  • Management reporting and ensure the timely delivery of different testing milestones, daily management of the software teams (scrum master)
  • Responsible for development and test operations – design, plan and execute
  • Collect information on team performance against contract, customer expectations, and project baselines
  • Supporting the development of a subject recruitment plan
  • Manage project budgets
  • Participate in proposal development and sales/proposal presentations
Education Education
Bachelor’s Degree in Related Field
Bachelor’s Degree in Related Field
Boston University
Bachelor’s Degree in Related Field
Skills Skills
  • Able to think analytically and to draw conclusions, possess strong analytical skills, with excellent problem solving abilities
  • Ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior
  • Proven ability to create a high performance culture which fosters On-Time-Delivery with Quality and Content
  • Solid verbal and written communication skills and able to take decisions even under pressure
  • Operational mind-set with focus on deadlines, detail and quality oriented
  • Organized and persistent: Able to prioritize, organize and get things done. Good at executing
  • Possess strong analytical skills, with excellent problem solving abilities
  • Ability to act as a technical driver for the rest of the team. Solid verbal and written communication skills
  • Ability to work independently and as a team member
  • Ability and aptitude to use various types of databases and other computer software
Create a Resume
1

Lead-external Medical Device Mfg Resume Examples & Samples

  • Lead external manufacturing cross functional teams with key business partners for medical device, combination product, and pharmaceutical products through clinical development, product registration and commercialization
  • Expertise in design controls, biocompatibility, sterilization validation, packaging validation, and shelf life stability programs
  • Works closely with the procurement team on contract vendor selection, outsourcing models, and vendor evaluation audits, for medical device partners and combination products
  • Establishing and fostering strong collaborative relationships with external design/development, manufacturing partners and service providers
  • Change owner for manufacturing vendor change notifications; lead or assists with manufacturing deviations, customer complaints and product failure investigations
  • Establish and maintain detailed project plans; define risks and recommend contingency plans as required
  • More than 10 years of experience in the field of medical devices or combination products development and commercialization is required
  • A Bachelors of Science Degree in Engineering, Biotechnology, or Life Science is required
  • A Masters of Science Degree or Masters of Business Administration preferred
  • Minimum of 5 years managing contractors and leading projects
  • Experience in developing and commercializing FDA regulated devices / combination products under design control regulations
  • Experience in supply chain handling, clinical manufacturing and distribution
  • Knowledge of industry standards (e.g.: ISO, AAMI, ANSI)
  • Strong managerial leadership skills with a track record of delivering new products to market with development partners
  • Strong communication skills (written and verbal), including experience presenting in front of multidisciplinary stakeholders
2

Medical Device Production Manager Resume Examples & Samples

  • Be responsible for the delivery of quality products on time to meet market demands
  • To implement and manage all manufacturing activity in compliance with company and ISO quality standards
  • To supervise the production personnel within the production area by administering company policies and procedures. Perform: hiring, job assignments, promotions, salary actions, disciplinary actions, and process performance reviews
  • To motivate and manage staff towards achievement of targets and objectives on an ongoing basis
  • Monitor and manage production costs and implement continuous improvement to increase capabilities and capacity of the manufacturing unit
  • Liaise directly with the material planner, suppliers and internal fabrication departments to ensure effective production levels
  • To liaise with design teams and engineering managers in support of New Product Introductions(NPI) and sustaining engineering activities
  • Provide regular production metric reports to the company management
  • Train production staff through effective leadership and coaching skills
  • Create and manage an overall Operations budget
  • Manage and control material inventory
  • Have created/established a manufacturing facility
  • A proven track record of managing a production team within high technology instrument manufacturing
  • Experience of staff management, appraisal, development and planning
  • Qualification in skills of project management and can demonstrate the application of these skills to management
  • Ability to motivate people and have strong communication skills
  • Knowledge and application of LEAN manufacturing principles to to implement continuous improvement techniques
  • Good interpersonal skills - able to express ideas, recognize good ideas and collaborate with cross-functional teams. Communication project status
  • Have an ability to plan, organize production and coordinate production to a high level
  • Basic knowledge of 3D CAD preferably Pro/ENGINEER would be advantageous
  • Six sigma green belt/black belt certified
  • Demonstrated ability to use process and quality control statistical methods to identify and correct/improve production processes
3

Finance Manager, Medical Device MNC Resume Examples & Samples

  • More than 8-years' experience in accounting and finance roles, with increasing levels of responsibility
  • Maintenance of Accounting certification, preferably US CPA, Australia CA, ACCA, or equivalent
  • Proficiency with SAP or other ERP system and with Excel, including pivot tables, lookups and other key functions
  • Knowledge of Philippines statutory and tax reporting requirements
  • Experience with US GAAP and Sarbanes-Oxley requirements
  • Firm commitment to professional standards and ethics
  • Curiosity attitude and possess strong business acumen
4

R & D Medical Device Engineer Resume Examples & Samples

  • Degree in Engineering (mechanical/electronics or industrial)
  • Experience within a Quality/GMP regulated industry
  • Process validation and manufacturing experience desirable
  • Polymer Science and/or Injection Moulding desirable
  • 3D spatial awareness and visualisation of concepts, mechanisms and assemblies
  • Ability to work in a team and on your own
  • Analytical approach to potential problems and opportunities
  • Good communication skills and initiative
  • Ability to meet challenging timelines
  • Keen to develop new areas of knowledge
5

Medical Device Marketing Leadership Opportunities Resume Examples & Samples

  • Brand Strategy
  • Consumer Insights & Analytics
  • Product Launch
  • Marketing Communication
  • Marketing Planning & Execution
  • Global Innovation & Pipeline
6

Medical Device / Systems Analyst Resume Examples & Samples

  • Analyze and investigate issues
  • Provides explanations and interpretations within area of expertise
  • Investigate non - standard requests and problems
  • Document and keep logs of past and current state
  • On - Call support on rotation
  • 1+ year of Helpdesk related experience
  • 3+ year supporting networked Windows PCs with external devices
  • 3+ years Wired / wireless device configuration
  • 1+ year Quality Assurance Testing experience
  • Basic level with MS Word, Access, Excel
  • Previous experience with issue research / resolution and error management in clinical applications and devices
  • Capable of providing own reliable transportation for local travel to specified sites to troubleshoot
  • Willing and able to work in an on - call rotation
  • Medical Device support - MRI, EKG, Mammography, X-Ray, etc
  • Network issue resolution
  • Previous experience with clinical and transcription related applications (Fuji / Synapse, PowerScribe, Vericis / Pyramis, Allscripts Enterprise, GE Centricity Business, and
  • GE Centricity RIS
  • Experience documenting workflows
  • Basic level with MS Office Visio
7

Medical Device Technical Specialist Resume Examples & Samples

  • Schedule, plan, perform and report audits of clients’ management systems to ensure compliance with regulatory and voluntary requirements
  • Assess and report on the sterility assurance aspects of medical device technical documentation and quality systems
  • Attend assessments as technical expert or provide expert briefing
  • Review critical data (including sterilization validation), routinely at the cutting edge of technology where no product standards or device experience exists, identify when additional external expertise is required, make safe recommendations for the issuing of BSI certificates
  • Deliver Medical Device CE Marking technical review, scheme management and ISO 13485 QMS assessment services as a fully integrated member of the Microbiology Team
  • Work with other team leaders as required to provide QMS assessment within area of expertise
  • Provide advice and support to product specialists and scheme managers on certifications in area of expertise that may have a regulatory challenge
  • Provide appropriate “Technical Sales/Networking” support to the commercial team
  • A degree-level qualification in Microbiology or equivalent biological science
  • Experience and successful completion of training in the routine control and validation of sterilization and microbiological testing (Aseptic fill may be accepted in lieu)
  • A minimum of three years’ experience in the medical device or pharmaceutical field
  • Hands-on experience of working as a microbiologist in the manufacture of sterile products
  • Thorough knowledge of Medical Device regulation
  • An appreciation of the concepts and intent of Product Certification and service orientation
  • Knowledge of business processes and the application of quality management standards
  • Conceptual and analytical thinking, with a keen focus on efficiency and delivering the right results
  • Team player mind-set and a proven track record of building good relationships, both internally and externally
  • Broad technical understanding of client industry products
  • Strong communications skills - fluent English is essential, additional languages a plus
8

Medical Device Test Lead Resume Examples & Samples

  • 8 - 10 years of experience in Medical device product verification, Regulatory compliance, Risk Management and SW Hazard analysis activities for Class I, II and Class III medical devices against FDA QSR 820, ISO 13485, AAMI TIR 45, FDA Validation guidance and IEC 62304 and GAMP-5 Computer System Validation (CSV)
  • Experience in EU Medical Device regulations and CE marking process and related SOP creation
  • Experience in working with Notified bodies and work experience in handling ISO 13485, EU notified body audits
  • Experience in ensuring Design Control compliance and Design History file( DHF) maintenance
  • Expertise in Test Management, Design verification Strategy and Planning, test execution, Regression test strategy, Design verification summary report ,defect report documentations and onsite-offshore coordination
  • Developed the SOPs for Design Verification, Validation, Design Output activities in line with FDA medical device regulations and IEC 62304
9

Medical Device Test Developer Resume Examples & Samples

  • 3-5 Years of Experience, with 1+ years of experience in Medical device testing
  • Knowledge or working experience in Automation
  • Experience working within a SCRUM/Agile environment
10

Medical Device Test Manager Resume Examples & Samples

  • 13+ years relevant experience , with 5+ years experience in Medical domain/ Medical device testing
  • Experience in SDLC and ALM
  • Knowledge of C#, C++ and VB
  • Windows test automation and automation framework implementation
  • Experience with Microsoft Team Foundation Server, Microsoft Test Manager, and MS tools
  • Knowledge or working experience in Coded UI Test
11

Medical Device IT Verification Engineer Resume Examples & Samples

  • Four-year Engineering degree (BE/BTech) in Information Systems, Computer Science or equivalent
  • 2-8 years of experience in IT industry as technical support, technical trouble shooter/bug fixer; experience as development engineer will be added advantage
  • Strong analytical and problem solving skills, you thrive on solving complex technical problems
  • Certification in testing tools or testing skills desirable, good understanding of statistics would be positive
  • Minimum of 70 % aggregate in graduation, XII and X standards
  • Knowledge of structured testing methods and processes, knowledge of several aspects of SW development concepts
  • Experience with communication standards e.g. ASTM, HL7, POCT1-A. (preferred)
  • Experience with integration engines like Microsoft BizTalk or Mirth. (preferred)
  • Experience in creating and maintaining reports using SQL Server Reporting Services (SSRS). (preferred)
  • Outspoken and with excellent communication skills. Strong customer focus and ability to interact with customers across the different regions in the world
  • Experience with medical device SW or experience from health care section is an advantage
12

Medical Device Test Lead Resume Examples & Samples

  • 5+ years relevant experience (BE/BTech), 3+ years relevant experience (MSc)
  • Proactive and self driven
  • Strong testing , trouble shooting and problem solving skills
  • Knowledge of C#
  • Windows test automation
13

Medical Device IT Test Developer Resume Examples & Samples

  • Responsible for SW features designing and implementation for MS Windows web services of the next generation acute care management of medical device
  • Four-year-degree (BE/BTech) in computer science, computer engineering, software engineering or equivalent
  • Certification in testing tools or testing skills desirable
  • 0-2 years relevant experience
  • Skillset: .NET developer (C#)
  • Test automation : Coded UI testing, Performance and scalability testing (Web performance testing), Security testing
  • Strong in MS tools and technologies : Microsoft Test Manager (MTM), Test Lab Center (lab environment), SCVMM (Hyper V environments)
  • Knowledge of SQL, Reporting service, Windows server, MSI, WMI and MMC
  • Structured and methodical, Excellent analytical skills and communication skills
  • Hands-on experience from several aspects of SW development
14

Medical Device IT Test Developer Resume Examples & Samples

  • Daily management of CI. Reporting to various project stakeholders
  • Participate in project-wide reviews of requirements, system architecture, and detailed design documents. Participate effectively in estimation, planning, cost-of-quality, and quality risk analysis is desired
  • Perform static analysis of source code using complexity metrics
  • Ensuring full compliance with relevant work practices, as required by authorities for medical device product development
  • Ensuring full compliance with Radiometers quality system
  • 5+ years relevant experience, Certification in testing tools or testing skills desirable
  • Must have relevant experience in manual SW Test execution, understanding testing environment (MS Server, SQL). Good knowledge of Web testing (HTML, Browsers), and capable of tracing SW work flow
  • Hands-on experience with MS tools and technologies such as Microsoft Test Manager (MTM), TFS
  • Experience of working in agile development methodologies with understanding of several aspects of SW development processes
  • Possess good analytical skills, with excellent problem solving abilities
  • Technical knowledge and experience, ideally in areas of software development for clinical and medical device development
15

Medical Device Engineer Resume Examples & Samples

  • Develop and validate test methods to support activities related to the selection, characterization, design verification, and commercialization and marketing of various drug delivery devices and novel injection tools for biologic therapeutics
  • Provide leadership in the validation of mechanical test methods
  • Review and validate mechanical test methods
  • Author method validation protocols and reports, and test methods
  • Initiate projects, define critical steps and resources, and develop practical and thorough solutions to complex problems
  • Work with limited direction and provide guidance and coordinate work activities of other personnel
  • Experience with mechanical testing methods (e.g. Instron) and test method validation as well as design controls for regulatory compliance and filing
  • Experience with data and statistical analysis (JMP, Minitab), DOE, and measurement system analysis (e.g. Gage R&R)
  • Strong organizational, communication, and interpersonal skills. Team oriented, dependable, self-starter. Strong computer and scientific skills. Excellent oral and written communication skills
  • Ability to work independently and as part of a team, self-motivation, adaptability, and with a positive attitude
  • Ability to learn new skills, perform multiple tasks simultaneously, attention to detail, keep accurate records, follow instructions, and comply with company policies
  • Bachelor's or Master’s degree in Engineering, or other related degree concentration with 10 years of experience in method validation
  • Experience in software validation desirable
16

Principal Engineer, Medical Device Resume Examples & Samples

  • BS Degree in Engineering, MS Degree preferred
  • 10 or more years of Medical Device Industry experience, including project management and development of drug device combination products
  • Profound knowledge of mechanical design and precision engineering for mechanic devices
  • Strong knowledge and professional experience in medical device development processes and applicable regulatory requirements
  • Significant working experience in multiple phases of the Engineering Lifecycle: design, prototyping, manufacturing, testing, process / design improvements
  • Relative experience with tooling / molding, assembly, testing (mechanical, performance, transportation) and packaging processes
  • Experience with providing leadership to international, cross-functional expert teams
  • Ability to facilitate decision making in a challenging environment
  • Fluent in English, German is a plus
  • Open and transparent communication style. ~BSP
  • Systematic, proactive and efficient working style. #LI-SA
17

Medical Device Program Manager Resume Examples & Samples

  • Advanced degree (MS, PhD, MBA) in engineering or business/management field
  • Project Management Professional (PMP) certification
  • Experience working within medical device development Quality Systems. (ISO 13485, 90001, etc)
  • Experience across the medical device development continuum, from concept development activities through product launch
18

Lead Medical Device Intergration Resume Examples & Samples

  • Minimum six (6) years of related experience
  • Minimum of 6 years work experience in healthcare IT or equivalent
  • 1 year of experience or formal course work with Microsoft Server 2003 (or later) environment
  • Be willing to Travel to KP sites as needed (approximate 5% travel expected)
  • Be available for an on call rotation basis, this includes weekends and holidays
  • Good written and oral communication skills (documentation creation is involved)
  • MCSE
  • Web App familiarity
  • Facilitate OS & database upgrades
  • Medical Device application experience
  • SharePoint Experience
19

Senior.medical Device Engineer Resume Examples & Samples

  • Minimum four (4) years of related experience
  • Minimum of 4 years work experience in healthcare IT or equivalent
  • Exceptional application analysis and design skills, as well as thorough trouble-shooting capabilities
  • Ability to lead a team in dynamic and rapidly changing environment
  • Tivoli experience
20

Medical Device Engineer, Sterile Products Resume Examples & Samples

  • Design and implementation of silicone and thermoplastic parts
  • Design of medical devices, including assembly and system integration, packaging, labeling, sterilization and related processing
  • Create design documentation, including requirements, specifications and process documentation (instructions, procedures, BOMs, etc)
  • Provide support for design verification and validation
  • Define and execute process qualification documents (PFMEA, PVP, TMV, IQ, OQ, PQ, etc)
  • Participate in medical device projects and provide project leadership on medical device development projects with primary mechanical design and production transfer responsibilities
  • Participate in medical device design reviews as project leader, participant and independent reviewer, as applicable
  • Provide manufacturing and production support of UT companies and partner locations
  • Proficient in Microsoft Office; Word, Excel, Access, Visio and Outlook
  • Prior experience with sterile product design, manufacture and packaging, and related standards
  • Advanced proficiency in Solidworks
  • Experience applying statistical analysis using analytical packages (MiniTab, Mathmatica, etc)
  • Proficient in ERP/MRP systems required related to Master data, BOM’s, production workflows and related topics
21

Medical Device Operator Resume Examples & Samples

  • Be passionate about providing manufacturing state-of-the art implantable medical devices
  • Working in a cleanroom manufacturing environment
  • Setting up and operating equipment
  • Performing data collection and entry
  • Following standard operating procedures (SOPs)
  • Manufacturing product with timeliness and accuracy
  • Making detailed and accurate observations
  • Working with EH & S and engineering to assure a safe work environment
  • Adapting and demonstrating flexibility by moving from one manufacturing area to another as needed
  • Manufacturing experience with small parts assembly
  • Excellent hand-eye coordination and fine motor skills
  • Extremely detail-oriented and organized
  • Superior accuracy in following written instructions
  • Effective communication skills, both verbal and written, with a demonstrated ability to positively influence teammates
  • Proven ability to set priorities
  • Flexibility to adapt and change to meet manufacturing and R&D needs
  • Possession of basic computer and math skills
  • Ability to
22

Medical Device Operator Resume Examples & Samples

  • Working with EH&S and engineering to assure a safe work environment
  • Flexibility to adapt and change to meet manufacturing needs
  • Experience initiating and completing projects
  • Leadership experience, including leading and sponsoring others
  • E1 experience
23

Medical Device Lead Auditors Resume Examples & Samples

  • To plan and conduct professional management system audits in accordance with SGS procedures to enable delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards
  • To assist in business development as required and to provide specific technical support to expand the Company’s capability to offer valued services to customers
  • To carry out specific project tasks in relation to medical devices procedures, processes, systems and documentation
  • Conduct Technical Files review specific for products being authorized for
  • Provide accurate and timely reporting as required by line management to assist the planning and management of operations
  • If required undertake reviews of packs and make certification decisions within target timescales and in line with SGS policies and accreditation/approval requirements
  • Manage personal schedule to work efficiently and to meet target chargeability requirements as defined by the Certification Manager
  • Undertake personal professional development and ensure appropriate training records and personal logs are updated to maintain relevant auditor registrations and relevant industry knowledge
  • Support business development activities as required (including follow up and/or referral of enquiries, sales visits, assistance at events, seminars, etc) to enable on-going growth of the business
  • Carry out internal audits of individual auditors, functions or offices to ensure internal compliance with relevant standards
  • Must be able to demonstrate and excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques (Essential)
  • Must be able to demonstrate a good knowledge of
  • Electro-medical devices (active devices); and/or sterilization and non active devices
  • Good experience with EN ISO 60601-1 3rd Edition and relative amendment; and/or Harmonised sterilization and cleanroom and on active medical device standards
  • Good experience with Risk Management EN ISO 14971:2012
  • Good knowledge of ISO 13485, MDD 93/42/EEC and their application
  • Good knowledge of Usability / Software standards such as 60601-1-6, 62366, 62304 and/or clean room and sterilization product standards
  • Effective interpersonal skills; able to develop good working relationships with people at all levels (Essential)
  • Must be IT literate i.e. competent in the use of MS Office applications and preferable experience of using large and complex databases (Essential)
  • Willingness to learn and adapt to change – committed to continuous personal and professional development (Essential)
  • Must have a detailed understanding of the relevant medical device regulations for with audits/technical reviews are being undertaken (Essential)
  • Must be currently working for or have worked for a Notified body as a Medical Device lead auditor within the last 6 months
  • Ideally able to demonstrate ability to identify and capitalise on any potential to maximise sales/revenue generated by the business (Desirable)
  • Able to motivate and lead others in a ‘project team’ environment (Desirable)
  • Work experience in positions with significant QA or management systems responsibility(Essential)
  • Medical device experience from auditing/work ( Essential)
  • Experience auditing against recognised standards (Essential)
  • Experience of working under own initiative and in planning and prioritising workloads (Essential)
  • Experience as a medical device lead auditor working for a notified body (Essential)
  • Experience of reviewing audit packs ( desirable)
  • GCSE Mathematics & English Language, or equivalent (Essential)
  • First degree, or equivalent vocational qualifications - i.e. BA/BSc, HND, Chartered Engineer, diploma etc (Essential)
  • Registered IRCA lead auditor, or equivalent registration under other recognised body (Desirable on entry, Essential within one year)
24

Medical Device Principal Engineer Resume Examples & Samples

  • Support overall project management, including software development, scope management, and release planning
  • Participate in the execution, documentation, review, and approval of all processes in the Software Development Life Cycle
  • Implement software designs for isolation of critical path or safety critical design elements
  • Review complex software design concepts prior to implementation
  • Participate in the integration of software implementations with system interfaces
  • Approve supporting documentation in order to secure project release
  • Anticipate project challenges and risk scenarios
  • Identify and execute proactive mitigation strategies to ensure optimal results
  • B.S. in Software Engineering, Computer & Electrical Engineering, Computer Science or related field
  • Required: 7+ years’ experience within and FDA regulated medical device industry
  • Well versed in software engineering disciplines with working knowledge of cGMPs and applicable industry standards
  • Thorough understanding of the Software Development Life Cycle (SDLC)
  • Experience integrating software and hardware, particularly in an embedded context
  • Experience reviewing, porting, and integrating third-party code, and using application frameworks
  • Intensive experience in micro-controller programming, preferably using 8051 & AVR RISC architectures
  • Familiarity with standard OS features (e.g. threading and concurrency, memory management, device drivers, I/O, etc.)
  • Strong C/C++ programming skills
  • Working experience with embedded RTOS preferred
  • Intensive familiarity with QNX or UNIX/Linux preferred
  • Experience in GUI application design
  • Experience in algorithm development, mathematical transformations, and protocol formulation preferred
  • Well versed in Design Control, Risk Analysis, Change Control, and problem solving (CAPA) preferred
  • Experience presenting concepts to a broad range of audiences from executives to software developers
  • Proven track record of software development effectiveness; leadership preferred
25

Medical Device Technician Resume Examples & Samples

  • Follows established department procedures to accurately verify and deliver the proper equipment by visually checking department requests and obtaining a verbal verification as needed
  • Delivers and/or sets up required equipment at various patient care areas throughout the hospital in a safe and efficient manner
  • Reports to the nursing unit and notifies nursing staff of equipment being delivered and/or pickup up and records delivery and/or pick up
  • Initiates or assists in transfer process of equipment from or to the Distribution department
  • Communicates to supervisor the completion of assigned duties and proceeds as instructed. If a delay or problem occurs in delivery of equipment, Distributor informs supervisor immediately and proceeds according to instructions issued
  • Provides directions and other helpful information to visitors and others while performing distribution duties
  • Returns equipment promptly to the appropriate area after pick-up and performs proper cleaning and infection control procedures. Performs basic operational check on all equipment made ready for distribution
  • Dresses in accordance with the dress code while adhering to proper hygiene when reporting for work and performing job duties
  • Adheres to the established policies addressing the confidentiality of patient information
  • Displays positive working relations with team members and customers throughout the hospital, communicating positively and appropriately
  • Assists in training new employees
  • Must be able to read, write, comprehend, and communicate the English language
  • Positive, helpful attitude toward customers
  • Ability to remain calm in less than calm circumstances
  • Flexibility, versatility, and reliability as a team player
26

Medical Device Prior Authorization Resume Examples & Samples

  • HS Diploma, GED, or technical certification in related field or equivalent experience
  • 3+ years experience in related field
  • Effectively applies knowledge of job and company policies and procedures to complete a variety of assignments
  • In-depth knowledge in technical or specialty area
  • Applies advanced skills to resolve complex problems independently
  • May modify process to resolve situations
  • Works independently within established procedures; may receive general guidance on new assignments
  • May provide general guidance or technical assistance to less experienced team members
27

Medical Device Operator Resume Examples & Samples

  • Working standard weekly hours: Monday through Thursday 3:15 p.m. - 12:15 a.m. and Friday 10:00 a.m. - 2:00 p.m., Monday through Friday or 3:15 p.m. - 11:15 p.m. (8-hour days)
  • Excellent track record of attendance
  • Understanding of manufacturing computer systems (i.e. Agile, MES and E1)
  • Experience working in a regulated industry
28

External Engineer Medical Device Company Resume Examples & Samples

  • Requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more biomedical engineering or other medical-related academic course of study
  • Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness. Stays abreast of and consults on technical advancements
  • Promotes the process of continuous quality improvement and risk management, and coordinates solutions for technical and project issues
  • Demonstrated ability to analyze and evaluate technologically complex devices; demonstrated written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills
29

Medical Device Analyst Resume Examples & Samples

  • Initiates and manages the complaint file
  • Maintains accurate entry of complaints in the database
  • Communicates to field representatives regarding information needed specific to products complaints (e.g. physicians, hospital personnel, sales representatives, international offices)
  • Independently assesses the complaint to determine if a medical device report needs to be filed with various global regulatory agencies (e.g. FDA, ECA)
  • Submits reports within required time frame
  • Diligent of any unusual trends in product complaints and communicates them with mgmt
  • Complies with US FDA regulations, other regulatory requirements
30

Medical Device Engineer Resume Examples & Samples

  • Will assist with the gap analysis on Design History Files
  • Completing the action items driven from the gap analysis, including conducting mechanical testing, updating drawings, conducting tolerance stack analysis, writing inspection procedures
  • Bachelor Degree in Biomedical Engineering, Mechanical Engineering or related field
  • 2+ years in development of implantable medical devices
  • Solidworks experience is a must
31

Medical Device Operator Resume Examples & Samples

  • Be passionate about manufacturing products that are the highest quality in their class
  • Working within a team in a controlled/clean-room manufacturing environment while wearing required clean-room garments
  • Setting up and operating manufacturing equipment
  • Performing hand assembly and visual inspection
  • Using measuring equipment
  • Collecting and entering data into a computer
  • Working independently and within a team as needed
  • Developing and maintaining strong interpersonal relationships
  • Maintaining excellent attendance
  • Being adaptable to support business needs, including moving from one manufacturing team or facility to another as needed (this may include some variability in shift hours between buildings)
  • One year of demonstrated, consistent work experience (full time 36-40 hrs a week)
  • Demonstrated basic computer and math skills
  • Good documentation skills
  • Quick learner
  • Problem solver
  • Self-directed and motivated
  • Task oriented
  • Safety oriented
  • Demonstrated ability to
  • Work independently and within a functional team
  • Demonstrated ability to be flexible and open to change
32

Head Device Development, Medical Device Unit Resume Examples & Samples

  • BS Degree in Science or Engineering
  • Minimum of 10 years’ experience in medical device development of complex technical products
  • Minimum of 5 years’ experience in drug-device combination development
  • Understanding of systems thinking (drug+container+device+software+app = system)
  • Advanced degree in engineering or life sciences
  • International business experience
  • Understanding of electronics and software development
  • Experience with Regulatory agencies; FDA, EMA
  • Language capabilities in French and German in addition to English
  • Primary container development experience
  • Experience with manufacturing and in particular high volume manufacturing
33

Medical Device Engineer, / II Resume Examples & Samples

  • Medical Device Engineer I: Bachelor of Science with five to eight years of experience in the pharmaceutical, biotech, device or drug delivery industry, or Masters of Science with three to six years of experience in the pharmaceutical, biotech, device or drug delivery industry, or Ph.D. with one to three years of experience in the pharmaceutical, biotech, device or drug delivery industry
  • Medical Device Engineer II: Bachelor of Science with nine to thirteen years of experience in the pharmaceutical, biotech, device or drug delivery industry, or Masters of Science with seven to eleven years of experience in the pharmaceutical, biotech, device or drug delivery industry, or Ph.D. with three to six years of experience in the pharmaceutical, biotech, device or drug delivery industry
  • B.S. or M.S. degree in Mechanical/Electrical/Biomedical/Material/Chemical Engineering, Pharmaceutical Sciences, or related applicable technical field
  • Understanding and experience of the principles and concepts within the area of device development in the pharmaceutical industry
  • Knowledge of the drug development process and the importance of the application of device development capability to this process
  • Basic knowledge and experience of other areas outside of own specialist area such as formulation and analytical development
  • In-depth knowledge of relevant compliance systems and experienced in authoring relevant sections in regulatory submissions (IND, IMPD, BLA, MAA etc.)
  • Experience with the development of devices for biotechnology compounds
  • Good communication skills and strong interpersonal skills are essential
  • Demonstrated leadership capabilities, organization, flexibility, and the ability to operate in a fast-paced environment
  • Ability to demonstrate up to date technical knowledge
  • Strong work habits and commitment to the position
  • Problem solving, a hands-on scientific approach, innovation and creativity
  • Ability to identify critical activities and prioritize tasks
34

Medical Device Operator Resume Examples & Samples

  • Setting up equipment and operation
  • Hand assembly and visual inspection
  • High school diploma, GED, or equivalent
  • Demonstrated one year of consistent work experience (full-time 36-40hrs a week)
35

Medical Device Operator nd Shift Resume Examples & Samples

  • Be energized by working for a world-class manufacturer and collaborating on cross-functional teams
  • Working within a team in a controlled/clean-room manufacturing environment with required clean room garments
  • Performing data collection/computer entry
  • Following Standard Operating Procedures (SOPs)
  • Demonstrated good verbal and written English skills
36

Medical Device Coordinator Resume Examples & Samples

  • Experience working as a Surgical Tech and/or Cath Lab Tech
  • OP Acute Care Coding experience
  • Familiarity with explanted items
  • Experience working with MS Excel
37

Category Manager for Consumer & Medical Device Resume Examples & Samples

  • BA/BS degree
  • Minimum of 3 years of experience in procurement or sourcing as a user or provider
  • Demonstrated functional experience or knowledge of at least one of the following is required: Clinical trials, IVRS, project management, laboratory services, GLPs, CMPs, GCPs
  • Ability to travel 10% domestic and international
  • BA/BS in Business, Life Sciences or related field
38

Senior Medical Device Engineer Resume Examples & Samples

  • May include but not limited to performing one or more processes within quality specifications while visually monitoring the machines/equipment used to ensure proper function
  • Ability to rotate through the assembly line, performing all production assembly operations
  • Performs on-line and in-process visual inspection of products to ensure it meets specifications per work order and procedure instructions
  • Assists Team Leader and Technicians with product and/or machine change-overs
  • Operates equipment at or above reasonable expectancy levels
  • Ensures product assembled meets quality standards
  • Rejects product outside of specifications
  • Adheres to safety standards
  • May operate a variety of testing equipment required for periodic product and process testing
  • Performs other related assembly and processing tasks, as required
  • Lifting -- Not to exceed 50 lbs. -- local practice may apply
  • Bending
  • Visual acuity
  • Color perception
  • Reading
  • Field of vision/peripheral
  • Fine motor skills
  • Noise
  • Chemical vapors
  • Soldering fumes
  • Education and/or experience equivalent to a high school diploma or certificate of leaving (Ireland)
  • Three months of assembly experience required
  • Previous experience of rotating through and performing all tasks on the assembly line including technical tasks requiring precise motor skills
  • Ability to visually check work performed and identify whether a product has been assembled correctly
  • Ability to follow instructions in performing repetitive tasks
  • Attentiveness in performing tasks
  • Ability to work as a team member in assembling sterile medical products
  • Ability to meet line rate expectations
39

Medical Device Resume Examples & Samples

  • Bachelor’s degree or equivalent experience
  • Passionate about data
  • Highly detail oriented with a critical degree of accuracy regarding data entry and analysis
  • Demonstrated project management success
  • Handles multiple conflicting business problems simultaneously under time constraints
  • Proficiency in MS Office applications
  • Knowledge of medical device types preferred
  • Healthcare/Medical device knowledge & Multi-Vendor biomedical service experience preferred
  • Experience with Salesforce administration a plus
40

Global Key Account Manager Medical Device Resume Examples & Samples

  • Foster business growth with existing clients and develop new opportunities in the Clinical Trials business with new customers
  • Co-ordinate and prepare customer proposals and budgets for new and existing business opportunities
  • Assess business impact of contracting opportunities to include overall profitability and impact on sales and margin
  • Supervise all customer orders are executed on time minimizing delays to customer
  • Liaise with the appropriate internal departments to ensure operations are running with no delays
  • Anticipate changes in the market environment and provide appropriate strategic recommendations maximizing our commercial objectives
  • Support the Global Clinical Trials Manager to implement the core business processes of SOP, NPI, to ensure Clinical Trials commercial delivery
  • Develop and streamline the commercial business processes with an aim to simplify processes whilst maintaining effectiveness
  • Bachelor's degree in Business or Life Science
  • Min 3 years of work experience required
  • Previous experience in strategic consultancy or in commercial function with pharmaceutical & medical device products. Experience in the Clinical Trials Market would be a plus
  • Self-starter who is target driven, thrives on success, ability to be autonomous and self-motivated
  • Critical for success: demonstrated analytical capabilities and problems solving skills, negotiation skills, and contract/legal experience, excellent oral and written communication skills
  • Innovative thinking: ability to identify improvement opportunities, challenge status quo and drive changes as required
  • Incumbent will demonstrate the necessary, self-motivation, attitude, confidence and leadership to work collaboratively with other commercial channels, across functions, with other divisions, functional peers such as Marketing, Contract Marketing, Credit/Finance and Account Sales & Services to deliver business results and solutions
  • Fluent in English, other languages are a plus
41

Medical Device Electronics Process Leader Resume Examples & Samples

  • Ensure the functioning and optimization of the production activities, to meet customer expectations
  • Investigates Customer Complaints as assigned
  • Conducts all phases of CAPA investigations as assigned
  • Creates document change packages resulting from the action phase of CAPA investigations
  • Works with the engineering team on product testing and design transfer activities of new electrical products
  • Works with the engineering team on product improvements
  • Assembly and testing of devices
  • Selection and procurement of alternate components for devices
  • Service and CAPA activities
  • Oversees service department, including the following responsibilities
  • B.S. or Engineering degree (EE preferred)
  • 5 to 8 years Electronic Medical Device manufacturing/service
  • Knowledge of GMP and ISO regulations
  • Troubleshooting skills in embedded systems, including the ability to read and follow electrical schematics
  • Basic knowledge of radiofrequency systems, function generator equipment and low voltage applications
42

Senior Specialist Medical Device & Combination Products Resume Examples & Samples

  • System Steward
  • Manage activities related to electronic quality systems, e.g. document and record systems, Trackwise Change Control and Trackwise Corrective and Preventive Action (CAPA), Success Factors training, etc
  • Assist with system configuration and maintenance
  • Maintain document and record integrity in electronic systems
  • Prepare for CAPA and change control meetings and manage meeting records and documents
  • Collect, graph and analyze data for quality metrics
  • Manage MDCP projects for Quality System Improvement Program (QSIP) activities
  • Document Steward
  • Write standard operating procedures and create forms and templates
  • Manage documents in the electronic systems through their life cycle
  • Create training materials for documents
  • Manage MDCP records
  • Training Steward
  • Create and manage training curricula for each MDCP job function
  • Effective interpersonal skills and ability to work collaboratively across diverse teams and networks; able to foster cooperation in others. Effective written and oral communicator. Able to speak up and contribute in a team forum. Able to apply prior experiences and learning’s in new settings, even if these are unfamiliar
  • Proven working experience in project management
  • Proven experience with electronic quality systems, e.g. document management, training, CAPA, change management
  • Proven experience authoring documents
  • Excellent client-facing and internal communication skills
  • Excellent written and verbal communication skills with experience presenting information at meetings
  • Solid organizational skills including attention to detail and multi-tasking skills
  • Strong working knowledge of Microsoft Office suite of software
  • Working knowledge of technical aspects of device development and commercialization. Development, product approval, and/or inspection experience with the medical device constituent of a combination product is an asset
  • Development and delivery of training is an asset
43

NTO QMS Medical Device Expert Resume Examples & Samples

  • Lead and participate in the harmonization and continuous improvement of the processes and Quality Management System across the different groups in Global Drug Development and Novartis Technical Operations. Oversee the implementation of the harmonized Quality Management System, ensure the continued effectiveness of the Quality Management System driving and/or coordinating mitigation(s) as appropriate
  • Lead projects associated with implementation of new standards and regulations. Assess, define and track actions to ensure that the Quality Management System is up-to-date to the relevant regulatory requirements. Keep up to date with new regulations in development, review and enforcement. Represent Novartis Technical Operations Quality Management System in the consultation processes for such new regulations
  • Oversee the implementation of the mid- and long-term strategies for the Quality Management System certification for medical devices. Support the appointed Management Representative in the corresponding interactions with Notified Bodies or other Competent Authorities
  • Ensure alignment of processes with Quality Management System relevant for medical devices. Act as Quality System Owner and author for selected Quality Management System and Global Operating Procedure. Review Quality Management System and Global Operating Procedure, provide review/comments and consolidation as medical device Subject Matter Expert
  • Report the status of the Quality Management System , provide review/comments and consolidation as medical device Subject Matter Expert
  • Report the status of the Quality Management System periodic management review meetings
  • Drive the preparedness activities for global medical device Quality Management System Audits and Inspections of "Notified bodies", authority inspections and internal / external audits and other regulatory bodies e.g. Food & Drug Administration. Coordinate the audit team during inspections. Support local groups when required for local medical device inspections. Coordinate and/or participate in follow up of Audits and Inspections
  • Manage Quality Events, monitor the progress of globally defined corrective and preventive actions to ensure the issues are adequately addressed, completed and appropriately documented
  • Works closely with IT Quality Assurance system project leaders to prioritize changes in Quality Management System and Global Operating Procedure together with the IT systems harmonization
  • Acting as back up for Compliance activities: Audit and inspection support on preparation, inspection, follow up and closure. Acting as Follow Up Responsible Person (FURP)
  • Lead and support selected global Device initiatives and projects and medical device networks
  • Participates at the Global Quality Management System Council, Quality Management System Governance Board and others as required
  • Responsible to follow up the Annual GXP training plans. Contribute to the development and execution of medical device trainings
44

Medical Device Closure Specialist Resume Examples & Samples

  • Product development and product engineering responsibilities for sterile Barrier Closure Systems
  • Technical contributor for CMR and NPI projects
  • Active member of 3M technical community that leverages Device Closure technology development across the company
  • Monitor competitive and industry trends to identify new opportunities for business success
  • Bachelor's degree or higher in a science or engineering discipline from an accredited institution
  • Minimum of one (1) year (academic and/or industry) medical device environment experience
  • Minimum of three (3) years Research & Development experience
  • Master's degree or higher in Chemical Engineering, Chemistry or Materials Science from an accredited institution
  • Experience in selection and development of device closure systems which may provide a sterile barrier for the product
  • Experience and knowledge in sterilization methods and how various methods affect both packaging and product
  • Proven ability to interact effectively within a pilot plant or manufacturing environment
  • Excellent verbal and written communication ability
  • Creative, self-driven individual with a track record of success
  • Detail-oriented with excellent organization skills
  • Passion for the medical device industry
45

Medical Device Regional Manager Resume Examples & Samples

  • Management and development of reporting staff. mentor others as appropriate
  • Background of success in value-based solution-selling
  • Ability to influence and lead both with and without direct authority
  • Executive-level business and financial acumen with strong negotiation skills
  • Ability to confidently speak in public, often for high-level executives
  • Ability to form and develop long-term strategic, interpersonal, professional senior-level relationships. display socially and professionally appropriate behavior
  • Ability to work independently, in groups and to effectively lead groups
  • Demonstrated leadership skills, initiative, critical-thinking and problem-solving skills
  • Strong organization, time- and project management skills
  • 50% travel
46

Medical Device Resume Examples & Samples

  • Design, plan and implementation of test cases, requirement based verification. Test script and test harness development and maintenance
  • Reporting to various project stakeholders
  • Build and maintain test automation via QTP
  • Provide testing expertise, including building up and maintaining test scripts and test harness
  • Create and execute test cases based on the system requirements specifications to ensure proper operation
  • Testing and verification of components, including module test and target test of new features as well as regression target test for release
  • Demonstrate Danaher values and adopt DBS tools across team
47

Medical Device Resume Examples & Samples

  • Responsible for designing and implementing state of the art software solutions with ability to own and drive a task, desire to act as a lead on a task force
  • Defines Product, System, Components objectives by analysing user requirements; envisioning system features and functionality
  • Participate effectively in estimation, planning, cost-of-quality, and quality risk analysis is desired
  • Completes applications development by coordinating requirements, schedules, and activities; contributing to team meetings; troubleshooting development and production problems across multiple environments and operating platforms
48

Medical Device Resume Examples & Samples

  • Responsible for architecting and designing features implementation approach for state of the art and complex software solutions within medical devices domain with ability to own and drive a task, desire to act as a lead on a task force
  • Participate in a design phase of new features and drive the flow from requirements to implementation with quality in mind. Defines Product, System, Components objectives by analysing user requirements; envisioning system features and functionality
  • 8-12 years of software development experience where of 5+ years in architecting .Net (C#) applications, Microsoft Certified Professional will be highly desirable
  • Must have experience and domain knowledge within the medical devices development industry
  • Strong skills in .Net C#, WPF, Design and Architecture patterns such as MVVM, MVC, MVP, Windows desktop application development experience
  • Optional experience with UX as part of the development process would be added advantage but not essential
  • Ability to act as a technical driver for the rest of the team. Solid verbal and written communication skills
  • Hands-on experience with MS tools and technologies such as Visual Studio, Nunit unit testing and mocking framework
  • Possess strong analytical skills, with excellent problem solving abilities
49

Medical Device Resume Examples & Samples

  • Motivate and empower the team, ensuring high performance and on Time Delivery of various projects
  • Ensure transparent communication with stakeholders from Radiometer outside of India
  • Ensuring full compliance with relevant work practices, as required by authorities for medical device product development and Radiometer quality system
  • General Software projects management, organize the status meetings and communicate the Status Report
  • Management reporting and ensure the timely delivery of different testing milestones, daily management of the software teams (scrum master)
  • Responsible for development and test operations – design, plan and execute
  • Understand the development and testing effort by analysing the requirements of the project. Estimate and obtain management support for the time, resources and budget required to perform the activities
  • 14+ years of professional work experience in software development projects and Managed teams for delivery
  • Working with medical devices and minimum 2 years of documented experience of leading teams and individuals
  • Must have experience and domain knowledge within the medical devices development industry and experience of working in agile development methodologies with understanding of several aspects of SW development processes
  • Must have experience with managing diverse teams of SW professionals, recruiting talent, developing people for optimal performance
  • Proven ability to create a high performance culture which fosters On-Time-Delivery with Quality and Content
  • Knowledge of C# (.Net Application), WPF, DB
  • Solid verbal and written communication skills and able to take decisions even under pressure
  • Able to think analytically and to draw conclusions, possess strong analytical skills, with excellent problem solving abilities
  • Organized and persistent: Able to prioritize, organize and get things done. Good at executing
  • Ambitious, performance oriented and able to work independently
  • Operational mind-set with focus on deadlines, detail and quality oriented
  • Flexible, willing to “go the extra mile” while at the same time being an agile and fast learner
50

Associate Medical Device Specialist, Vascular Resume Examples & Samples

  • Responsible for exhibiting competencies with the Teleflex Vascular product line
  • Responsible for exhibiting understanding of Teleflex Vascular Competition
  • Responsible for completing and sending in expense reports with the appropriate documentation in accordance with company policy
  • Responsible for assisting Marketing Department on surveys and gathering customer and competitive information
  • Responsible for assisting in National and local trade shows, cadaver labs and training programs when requested
  • Responsible for participating in quarterly and national sales meetings
  • Responsible for consistently updating customer database through SF.com and communicate those updates to Sales and Marketing counterparts
  • Responsible for filling out customer complaint forms on a timely basis and sending to Quality Assurance
  • Responsible for sharing competitive information with home office staff, their RSM counter-part and Area Manager
  • Responsible for consistently prospecting for new customers
  • Responsible for taking proper care of Teleflex products in their possession
  • Responsible for prudently managing their company expense account
  • Responsible for making sales presentations in accordance with the Teleflex Code of Conduct
  • Responsible for participating in designated conference calls
  • Responsible for following up on requests made by Regional Sales Managers/Area Director
  • Responsible for assisting in, creating and initiating strategies and tactics to increase utilization in the RSM’s sales territory
  • Bachelor’s degree (BA/BS) from a four-year college or university
  • Proven track record of success in sales
  • Able to spend a significant amount of time (60 - 70%) traveling in the U.S
  • Advanced level proficiency with computer skills (MS Office, Word, Excel and PowerPoint)
  • Outgoing with a positive attitude
  • Possess a valid driver’s license and operate a motor vehicle with satisfactory driving records
  • Carry detail bag weighing up to 20 lbs
  • Lift equipment weighing up to 30 lbs
  • Be standing or walking in numerous hospitals or at meetings for 6 – 10 hours per day, up to five (5) days per week
  • Interact with others through effective, verbal communication
51

Medical Device Package Manager Resume Examples & Samples

  • Regular attendance and punctuality
  • Develop/improve processes in the Package Testing Lab
  • Guide clients to appropriate testing requirements
  • Provide Medical Device packaging expertise to internal/external customers
  • Sample preparation, physical testing, and generation of test reports
  • Conduct testing in accordance with written SOPs and industry standards, following Good Laboratory Practices (GLPs) and/or Good Manufacturing Practices (cGMPs)
  • Responsibly manage data in Laboratory Information Management Systems (LIMS) and Laboratory Notebooks
  • Develop technical reports of test results following defined documentation procedures
  • Ensure proper maintenance and operation of test equipment
  • Assist in equipment qualification and development of SOPs
  • Assist in receipt/storage of customer samples
  • Demonstrate and maintain awareness of technical innovations and progress in package testing
  • Share in maintaining tidiness of laboratory
  • An understanding of mechanical testing techniques for medical device packaging, including testing standards in ASTM D4169 and ISO guidelines
  • Will have a hands-on approach to setting up testing equipment, with the ability to teach and coach subordinate technicians
  • Effective writing skills for production of technical reports, standard operating procedures, and would be able to compile data for client reporting
  • Advanced understanding of the Medical Device industry or package design industry. A candidate may not have direct experience in medical devices packaging, experience with package design and testing protocol would be considered
  • Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
  • Bachelor's degree in engineering or other related degree concentration, or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)
  • Ten years Medical Device Packaging experience, or related package design testing experience
52

Medical Device Reprocessing Coord Resume Examples & Samples

  • Overseeing or taking an educational role in device preparation (pre-cleaning and decontamination) in readying product shipment to Medline ReNewal. Making recommendations and improvements as necessary
  • Identifying products that are able to be reprocessed and then offering suggestions to key personnel regarding savings opportunities
  • Taking part in In-Service sessions as directed by Account Manager or Regional Sales Director
  • Conducting 1-on-1 and small group feedback discussions and use of survey tools to gather information
  • Must live in the general area of Oklahoma City, OK
  • Must have valid driver's license, clean driving record, and dependable vehicle with insurance to use in travelling between multiple hospitals
  • Demonstrated customer care and support skills with an emphasis on responsive, proactive support
53

Medical Device Development Engineer Resume Examples & Samples

  • Requires Bachelor’s degree in ME, EE, IE, OE, BME, or other relevant field with 8+ years of experience in the design, development and manufacturing of a product (device, part, component, etc.), preferably in the medical device industry
  • Prepare and implement small single discipline project or subprojects of an integral project, in accordance with agreed conditions on specification, time, cost and staffing
  • Responsible for execution, progress, and quality of the project. Small project, mainly reuse (of in-product HW,SW,E in case of a technical project)
  • Planning, leading, and tracking Leads a small team of approximately 5 team members
  • Microscope experience
  • Previous experience in a Controlled Environment Area
54

Medical Device Reports Specialist Resume Examples & Samples

  • Ensure complaint investigations are adequate, accurate, detailed and timely
  • Perform tasks to obtain adequate information to ensure proper documentation and closure of each complaint
  • Collaborate with appropriate technical, Clinical, Field/Sales and/or returned product analysis employees to determine reporting eligibility
  • Complete electronic submission of MDRs to the FDA
  • Ensure accurate data entry, scanning, and retention of documents to complete event files
  • Complete projects as assigned and required specific to post-market quality and complaint handling
  • Knowledge of CRHF products and therapies
  • Experience with complaint handling, MDR/Vigilance reporting
  • Solid knowledge of word processing, spreadsheet, database and presentation applications
55

Senior Medical Device Engineer Resume Examples & Samples

  • Assuming full accountability for the management of individual cases (Inquiries & Complaints) in our Blood Gas and Electrolytes System business according to regulatory and ISO Quality system requirements and needs of the Country Organizations In a timely manner
  • Collecting all relevant data and evaluating each escalated complaint to determine if investigation is needed
  • Resolving cases and preforming correct processing and documentation for individual cases according to applied medical standards and quality system
  • Communicating evaluation/investigation results to Affiliates and other global interfaces
  • Collaborating with investigation teams to ensure an efficient approach for root cause analysis and with Business Area and global functions, and ensure appropriate measures from cases are derived
56

Medical Device Leadership Development Program Resume Examples & Samples

  • Complete 9 month comprehensive rotational program in various departments and gain insight and understanding of different functional roles and departments that support the Field Sales Organization
  • Develop and implement a proactive plan that involves clinical and service support, with Region Managers and team members, to maintain market share and increase the quality of service to customers
  • Advance our mission of transforming lives through innovative medical solutions that improve the health of patients around the world
  • Conduct excellent product in-servicing, product evaluations, and continuing education programs
  • Assist in the BSC sponsored professional education activities by participating in on-site and field training workshops
  • Provide timely updates to multiple managers including business activities, competitive conditions, industry trends, etc
  • Prepare comprehensive plans, by account, which reflects overall Endoscopy Division strategy
  • Maintain accurate records of sales expenses, customer files and field sales reports required
  • Conduct all sales activities according to Travel & Entertainment (T&E) guidelines, Industry and Integrity Policies
  • Undergraduate degree in Business / Engineering, or other technical / relevant coursework
  • Strong record of academic achievement and leadership experiences
  • Demonstrate analytical, technical, communication and problem solving skills
  • Able to build and maintain strong customer relationships
  • Must be energetic, enthusiastic, determined and goal oriented
  • Willingness to relocate within in the US and open to significant regional travel (up to 70%)
57

Senior Medical Device Resume Examples & Samples

  • Provide practical legal counselling and commercial contracting support for the applicable businesses R&D, clinical research, procurement, manufacturing, logistics, marketing, sales, and service activities
  • Coordinate and facilitate other related business initiatives when applicable; and
  • Develop and deliver internal training materials to your clients with respect to compliance and legal matters related to all of the above
  • Providing successful legal commercial/transactional support for the development, purchase and sale of medical devices and services; software maintenance and support; clinical research trials - both sponsored and investigator initiated studies; procurement and other consulting services
  • Litigation management
  • Applying health care Compliance laws (i.e. among others Medicare Fraud and Abuse, Discount and Personal Services Safe Harbors, and Sunshine Law)
  • Applying FDA regulatory guidance as part of a team to commercial and clinical research activities
  • Identifying business and legal risks and offering creative solutions and counseling based on a reasonable balance of the applicable issues and risks; and
  • Providing clear ethical guidance in all aspects of work
  • Counselling on the proper use of health care and other personal data for R&D, marketing, and other commercial uses, under HIPAA and other applicable law
  • Managing product liability litigation matters with outside counsel, advising on marketing claims development for direct to business and consumer advertising, advising on marketing and sales programs from a compliance perspective; and
  • Prior experience negotiating clinical trial agreements with hospitals and research institutions is a plus
  • J.D. from an accredited U.S. law school and admission to a state bar
  • A collegial, cooperative and an open person who enjoys being a team player and builder in a rapidly changing environment, and feels comfortable working in a global environment on projects involving professionals from around the world
  • Persuasive presentation and counseling skills
  • Excellent contract drafting skills
  • Strategic thinker
  • A keen interest in all types of technology
  • A passion about improving how health care is delivered
58

Medical Device Collection Tech Resume Examples & Samples

  • Coordinate the packing of devices in Medline ReNewal shipping containers (employing proper techniques to ensure safe shipment of product)
  • Update the Medline ReNewal Collection Container Locations sheet to provide an accurate record of where all containers have been placed throughout the facility
  • Provide support to in-service sessions as directed by the assigned Account Manager
  • Make regular rounds throughout the facility; initially to introduce self and Medline ReNewal, and eventually to help answer questions and share any staff concerns with the assigned Account Manager
  • High School Diploma (GED) preferred
  • Residence in the Bryan, TX area or employment at CHI St. Joseph Hospital preferred
  • Ability to regularly lift at least 30 pounds as a regular part of daily tasks
  • Ability to begin work at an early hour (i.e. 6AM) to align with the schedules of facility staff members
  • Able to be credentialed at the highest level in order to gain admittance to all required rooms within each designated facility
59

Medical Device Collection Technician Resume Examples & Samples

  • Establish and follow a regular schedule to visit the assigned facility in order to collect devices in the designated containers
  • Arrange for shipment of collection containers in a timely manner
  • Ensure program supplies remain stocked for use; distribute program collateral throughout the facility as directed by the assigned Account Manager
  • Residence in the Syracuse, NY region
  • A current valid driver’s license, vehicle insurance, clean driving record and ability to travel in own vehicle to designated facility
  • Good communication skills; especially on a verbal level
  • Strong organizational skills and attention to detail to complete work tasks in a thorough manner
  • Self-initiative and dependability to reliably perform the job in an independent setting
60

Medical Device Engineer Resume Examples & Samples

  • Performs routine engineering assignments of related tasks which are typically a focused portion of larger projects. These tasks provide experience and familiarization with the engineering staff, methods, techniques, theories, Corporate and division SOP's, policies and projects
  • Document development work including writing specifications for manufacturing or scientific test results
  • Ability to solve routine design and engineering tasks with some assistance. Able to solve problems with periodic monitoring
  • Assists in the preparation and participation in technical reviews and responsible for organizing data and preparing appropriate documentation for assigned projects
  • Ability to discuss normally encountered technical or project management issues, both verbally and in written form
  • Ability to work as a collaborative team member
  • Ability to solve routine design, engineering problems with assistance
  • B.S. and 3 - 5 year related experience (in-house, co-op or acquired outside)
61

Medical Device Reprocessing Coordinator Resume Examples & Samples

  • Making regular rounds throughout the facility to address questions / concerns and assist in device flow processes
  • Educating and training staff on the value of reprocessing and reprocessing best practices
  • Must be able to receive and maintain hospital certification (multiple vaccinations required) to access assigned facilities
  • Demonstrated aptitude to build relationships, obtain buy-in from key personnel and successfully “market” self as a value-add resource, as well as Medline ReNewal as a trusted partner
62

Development Engineer Medical Device Resume Examples & Samples

  • Provide project and technical leadership on cross-functional team for devices through preclinical development, product registration and commercialization
  • Lead all project execution activities and oversee the development of statistically sound design verification protocols/reports and design validation. Responsible for clear, concise, well written design history documentation, EU technical files, and manufacturing specifications
  • Establish maintain detailed project plans define risk and recommend contingency plans
  • Lead the creation of design control elements to comply with medical device regulations to support the development of products in accordance Product Development Process and Design Control requirements as well as compliance with Good Manufacturing Practices (Quality Systems Regulations), Standard Operating Procedures, and Safety requirements
  • Establish and foster strong collaborative relationships with external design/development, manufacturing partners and service providers
  • BS degree in Engineering required Master’s degree preferred
  • 6 + years medical device experience coupled with development and commercialization success
  • Strong hands on experience in injectable biomaterials based device design/development ideal
  • Technical leadership experience with biomaterials delivery system development and scale-up
  • Leading projects with external design, development and manufacturing partners
  • Experience in developing and commercializing regulated devices / combination products under Design Control (21 CFR 820) and ISO13485 requirements, DFSS certification is desirable
  • Strong communication skills (written and verbal), including experience presenting in front of cross-functional audiences
  • Must be able to multitask, handling a variety of projects simultaneously
63

Risk Manager, Medical Device Resume Examples & Samples

  • Demonstrable experience of Risk Management and Design Controls (preferably in the area of user-focussed Risk Management) in Medical Device or Pharmaceutical Industry
  • Strategic thinking in the inter-relationship between user-focussed risk management and device design and development
  • Experienced in ISO and FDA regulations and standards as applicable to device design and risk management
  • Appropriate Science or Engineering Degree
  • Excellent verbal and written communicator; clear and concise in communications with internal and external partners
64

Medical Device Operator Resume Examples & Samples

  • Working in a cleanroom manufacturing environment manufacturing implantable medical devices
  • Setting up equipment and operating in a multitask environment
  • Performing data collection/entry within manufacturing data collection systems
  • Following Standard Operating Procedures (SOP's)
  • Performing all manufacturing operations as required to support business needs (This may include some variability in shift hours.)
  • Demonstrated one year of consistent work experience (full-time 36 - 40hrs/week)
  • Previous experience with manufacturing equipment and tools
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Medical Device Technician Resume Examples & Samples

  • Will perform PM's and repairs on a variety of biomedical equipment
  • Will mentor and assist PM technicians as required
  • Will identify training needs for self
  • Will assure the service area is clean and orderly, providing a safe environment for service personnel
  • Will assure accurate database entry and reports
  • Expected to meet production goals set for department
  • Will participate in department on call rotation
  • Some knowledge of various hospital / homecare medical equipment
  • Excellent customer communication skills
  • Computer literate with an understanding of database operations
  • Understanding of and ability to operate basic electronic test equipment
  • Basic knowledge of electronics, electricity, electro-mechanical, fluidics, pneumatics and hydraulic theories and practices
  • Associate's Degree in an electronic field, preferably biomedical, or a combination of education and experience
  • Strong attention to detail, ability to maintain focus with intermittent distractions
  • Ability to communicate with all levels of personnel
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Temp to Hire Medical Device Assemblers Resume Examples & Samples

  • This position requires demonstrated communication skills and the ability to withstand repetitive motion
  • High school diploma or GED or equivalent
  • Must be able to demonstrate conversational English
  • Must be able to demonstrate the potential ability to perform the essential functions of the job as outlined in the duties and responsibilities
  • Must have the ability to lift up to 50 lbs
  • Have good hand/eye coordination and ability to handle and manufacture small and delicate parts
  • The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive
  • Completes during the manufacturing process: cuffing, gluing, assembly, hand marking catheters, and running leak, packaging, prep, removing flash, cleaning components, setting pins, lead testing and pull testing
  • Follows safety guidelines; GMP and Hazmat
  • Follows applicable Standard Operating Practice and drawings
  • Checks to verify procedures and revisions
  • Monitors processes for rejects or deviations from quality standards
  • Perform rework and scrap
  • May be called upon to complete other tasks as needed and assigned by the Supervisor
  • *Please do not contact the local Kelly Services branch as they are not recruiting for this position. For immediate consideration, please reply directly to this posting or email your resume to shac759@kellyservices.com ***
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Associate Medical Device Specialist Resume Examples & Samples

  • Account maintenance visits
  • Account inventory checks
  • Assist with account in-servicing upon sales close of new business
  • Thorough understanding of BIS product offerings through in-house product training and account procedure observations
  • Clinical support staff interviews to obtain information relative to products, competition and challenges
  • Assist with product evaluations as needed
  • Assist MDS where needed so that he is able to pursue new business opportunities
  • Knowledge of hospital structure, BIS products and prior sales experience is desired but not required
  • Ability to work a very large territory with overnight travel
  • Follow through on projects and tasks with direction from MDS, Bill Corbin
  • Ability to work well independently and within a team environment
  • Interact with a diverse group of people at all levels
  • Portray a professional image
  • Ability to follow direction well
  • Understand products and services thoroughly in an apprentice role
  • Business travel is at least 70% of the job
  • Driver’s license required
  • Residence in major metropolitan area within territory
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Global Quality Coordinator, Medical Device Resume Examples & Samples

  • Develop and implement an effective Global Post Market Surveillance program within Bauer, including analysis, trending, reporting of product issues to regulatory agencies and the resolution of product complaints
  • Act as principal contact for 3rd party audits and regulatory inspections of Bauer medical device operations, including planning, preparation, execution, reporting results, and follow-up
  • Ensure the effective development and maintenance of the Bauer medical device design and development files and risk management files, including Hazards Analysis, Use FMEA, Design FMEA and Process FMEA
  • Partner with Bauer vendors to develop business relationships and ensure their compliance to GMP, and where necessary, their conformance with the requirements of ISO 13485, to facilitate the completion of Supplier Corrective Actions
  • Stay current with global regulatory requirements
  • Conduct training of internal and external stakeholders
  • Perform other duties and responsibilities as needed
69

Medical Device Resume Examples & Samples

  • Ability to clearly, concisely and accurately convey communications
  • Ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior
  • Ability to work independently and as a team member
  • Demonstrated initiative and problem-solving skills; analytical and critical-thinking skills
  • Ability and aptitude to use various types of databases and other computer software
  • Ability and aptitude to provide solutions and contingency plans through the comprehensive review of alternatives
  • Ability to present material to Executive-level management
70

Medical Device Operator Resume Examples & Samples

  • Be passionate about providing manufacturing state-of-the art medical devices
  • Standard Weekly Hours: Monday - Thursday 3:15 p.m. - 12:15 a.m., Friday 10:00 a.m. - 2:00 p.m. OR Monday - Friday 3:15 p.m. - 11:15 p.m. (8 hour days)
  • Demonstrated small parts assembly
  • Work in a cleanroom environment and wear cleanroom garments
  • Able to work with small parts, with good hand/eye coordination
  • Must have ability to work independently and function effectively as a member of a large team
  • Must be extremely detail-oriented and organized
  • Must possess basic computer and math skills
  • Must be self-directed and motivated
  • Must have effective communication skills, both verbal and written
  • Ability to make detailed and accurate observations
  • Demonstrated ability to positively influence teammates
  • Flexibility to adapt and change to meet manufacturing need
  • Work the scheduled shift and overtime as needed by the business
  • Basic computer skills with the ability to learn more advanced systems
71

Medical Device Installation Technician Resume Examples & Samples

  • Under supervision, evaluate and implement setup and preparation of medical equipment
  • Associate’s or Bachelor’s degree in Electrical Engineering, Biomedical Engineering,Mechanical Engineering, or related field; OR equivalent military education; OR participant in the formal GEHC Biomed/FE Services Internship or Military Externship program; OR High School Diploma/GED and 2+ years of experience servicing electrical, electronics, IT or mechanical equipment
  • Analytical and communication skills with the ability to communicate technical issues to the customer in an easy to understand manner
  • Candidate must be able to lift, carry, push, and pull up to 35 lbs. unassisted and frequently bend, stoop, twist, climb, crouch/squat, kneel/crawl, sit and stand for long periods of time
  • Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, please use the “SUBMIT RESUME” button below to submit your resume. If you have questions about the position, you may contact the recruiter recruiting for this position (beth.stumbaugh@kellyservices.com). Your resume must be received via the “SUBMIT RESUME” button included within**
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Medical Device Reprocessing Pgm Coord Resume Examples & Samples

  • Assisting in the OnDemand training process and setting up designated system users for Auto Notifications
  • Observing cases and monitoring case flow to ensure optimum reprocessing steps are taking place (or to identify areas of improvement)
  • HS Diploma required
  • Must live in the general area of Wausau, WI
  • Strong interpersonal and communication skills (oral and written); must be fluent in English
  • Strong organizational and time-management skills; ability to apply structure and self-discipline within day-to-day work regimen to achieve goals
73

Territory Manager Joints Medical Device UAE Resume Examples & Samples

  • Identify achievable and relevant quarterly target customers in all segments that lead to meeting annual Business Plans
  • Accomplish quarterly, monthly and weekly priority sales goals through efficient use of time and resources
  • Routinely follow the sales process in order to consistently advance target customers along the selling cycle
  • Continuously expand knowledge necessary to represent our complete product line to all customer segments in a professional manner
  • Routinely ensure customer satisfaction with all products by providing education in proper product application, features functions and benefits
  • Manage business relationships and external/internal customer communications in a cooperative, timely and efficient manner
  • Scrubbing with surgeons inside OR
  • Good knowledge of Arthroplasty orthopedic business in medical device sector
  • LIVE OUR CREDO: Demonstrate and inspire the behaviors that reinforce Our Credo
  • CONNECT: Develop deep insights into the needs of our patients, customers, markets and communities
  • LEAD: Create an environment where leadership and talent development is top priority
  • DELIVER: Deliver results by inspiring and mobilizing people and teams.1700178273W
74

Medical Device Resume Examples & Samples

  • Monitor and manage efforts of cross-functional project teams
  • Define project workloads and assignments
  • Mentor project managers and support staff
  • Meet with team members on a regular basis regarding project tasks to ensure project milestones are met
  • Collect information on team performance against contract, customer expectations, and project baselines
  • Lead problem solving and resolution efforts
  • Develop and maintain internal databases and project plans
  • Supervise maintenance of project management information and tracking systems
  • Manage project budgets
  • Produce and distribute reports and presentation materials
  • Provide input to line managers of project team members' performance relative to project tasks
  • Participate fully in proposal development, participate in bid defense presentations in partnership with Sales and senior Project Management staff; provide input on scope and budget development
  • Implement continuous improvement activities for assigned projects
  • May have supervisory responsibilities for project support staff
75

Medical Device Associate Resume Examples & Samples

  • 2012-2016 JD: Top schools/grades required
  • Experience counseling device and diagnostics companies ranging from start-up ventures to multinational manufacturers, clinical laboratories, and industry trade associations
  • Additional work experience advising clients on post-market compliance issues, adverse event reporting, field action, and advertising and promotion requirements and also preparing materials for pre-market clearance and approval of new medical devices preferred