Design Assurance Engineer Resume Samples

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E Mills

Estevan

Mills

8637 Jamey Stravenue

New York

+1 (555) 264 1428

8637 Jamey Stravenue

New York

Phone

p +1 (555) 264 1428

Experience Experience

Philadelphia, PA

Design Assurance Engineer

Philadelphia, PA

Kuhic Group

Philadelphia, PA

Design Assurance Engineer

Plans, conducts and executes design assurance activities requiring judgment in the independent evaluation, selection and the substantial adaptation of standard mechanical engineering techniques, testing procedures and criteria
Performs and documents all engineering studies and reports to satisfy the master verification plan
Participates with the engineering team to establish and review the design FMEA
Routinely provides design assurance guidance and direction to engineers and/or technicians for the duration of a project assignment
Support various QA/RA activities including quality management, system reviews, audits, etc
Evaluation of new products, assuring the safety and efficacy of the devices
Design verification and shelf life protocols / reports review

Phoenix, AZ

Associate Design Assurance Engineer

Phoenix, AZ

Torp and Sons

Phoenix, AZ

Associate Design Assurance Engineer

Provide Design Assurance Engineering (DAE) and technical quality support to project teams in the Product Development Process or in support of post market changes
Support the pilot manufacturing line by performing Quality Review and NCMR support
Support the execution of all design verification and validation activities including the overseeing testing. Coordinate with all supporting functions (e.g. Test Lab, Microbiology, etc.) to meet project milestones
Participate in risk management activities including the creation of the preliminary hazard analysis, Design-FMECA, Post Market Surveillance (PMS) Reports and support risk management document changes due to post market quality activities (PEC, PIA etc)
Support R&D, Operations, Regulatory Affairs and Component Engineering during all product development phases
Serve as a quality extended team member on new product development project teams or post market change teams
Provide support for the creation of design control documents, such as specification documents, process instructions, and receiving inspection documents

present

Chicago, IL

Senior Design Assurance Engineer

Chicago, IL

Herman, Corkery and Bogisich

present

Chicago, IL

Senior Design Assurance Engineer

present

Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Knowledge of Risk Management
Responsible for assisting in compiling and reporting on Vendor performance statistics
Responsible for writing and/or assisting in the writing of test and inspection SOPs
Provides project direction, coaching, and mentoring for engineering and technical team personnel
Knowledge of Project Management
Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues

Education Education

Bachelor’s Degree in Engineering

North Carolina State University

Bachelor’s Degree in Engineering

Skills Skills

Ability to apply and integrate knowledge of other related engineering areas to own areas of expertise
Excellent written and verbal communication skills. Good presentation skills
Independent thinker, strong leadership skills, ability to organize complex work, drive change and promote a culture of execution
Knowledge of engineering theories and methods
Working knowledge of Minitab and tools such as Design of Experiments, Process Capability Studies, Failure Mode and Effects Analysis, Statistical Process Control, Industrial Statistical Methods and Lean Manufacturing
Proficient in analytical packages (MiniTab, Mathmatica, etc)
Microsoft Office Proficient (Word, Excel, Access, Visio and Outlook)
Proficient in PLM/ERP (including document and change control)
American Society for Quality certification
Experience with and understand of ISO 15223, ISO 14971, IEC 60601, IEC 62304, IEC 62366, ISO 10993, ISO 14644 and USP/EP standards

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Design Assurance Engineer Resume Examples & Samples

Works closely with product development engineering and the client team to establish the system design specifications and product requirements
Performs and documents all engineering studies and reports to satisfy the master verification plan
Routinely provides design assurance guidance and direction to engineers and/or technicians for the duration of a project assignment
Root cause investigations; drive problem solving efforts for quality issues
Generate and approve change requests
Root cause analysis and implementation of corrective action for process related concerns
Working with Program Managers and Process Engineers to co-ordinate and prepare sample submission packages, updates and maintains the FMEA's, Process Flow diagrams and Process Control Plans
Candidates must have 3-5 years of relevant experience with a Bachelors degree or higher in Engineering, or a related discipline
Must be able to work independently and as a member of a cross-functional team, to multi-task and do what it takes to meet high expectations and tight deadlines. Will be working on highly visible projects in high-pressure situations
Must have good written & oral communication skills and the ability to communicate appropriately with different engineering teams, Product Management, vendors and partners, and customers
Must be able to travel occasionally to meet with customers / project teams

Design Assurance Engineer, Principal Resume Examples & Samples

Design Assurance: (50%)
Leadership (15%)
15 Years of experience
Engineering experience in systems design, automation, real time and safety critical control systems, systems modeling, application and programming of general purpose computers and PLC's, ability to read schematics (i.e. electrical, pneumatic, hydraulic) and quality assurance (required)
Previous experience in Theme Park Industry (required)
Previous experience in Hazard Analysis, Fault Trees and FMEA (required)
Strong communication and presentation skills (required)
Strong computer skills - programming (required), word processing (required), spreadsheets (required)
Ability to Travel (approx 25% of time, some long continuous > 9 months)
Strong leadership (effectively communicating design vision, mentoring engineers, and providing engineering guidance to the Resort) and interpersonal skills (tactful and diplomatic communication with people at all levels of the organization, cooperation with other team members, and the power to persuade), both with internal staff and with other outside entities within Parks and Resorts
Effective under stress. Able to react and perform efficiently under pressure
Demonstrated communications skills at all levels, including presentations to executive level staff
Set example of what is expected of staff in a wide variety of personal performance aspects such as: dependability, clarity of communication, fairness, dedication, initiative, thoroughness of analysis, openness, and trust
Desire to continuously learn, assessing current and new means and methods while seeking training/development opportunities that apply to cast and self
Excellent work ethic which translates to working the required hours in order to ensure a quality design and completion of the task/project on schedule and within budget
Planning and organization: The setting of objectives, creating and realizing a plan of action, while making the best possible use of resources.Delegation: The entrusting of a clearly set-out responsibility to an appropriate individual combined with follow up to ensure desired outcomes are achieved
Delegation: The entrusting of a clearly set-out responsibility to an appropriate individual combined with follow up to ensure desired outcomes are achieved
Previous experience in testing and instrumentation (preferred)
Thorough knowledge of and familiarity with US industry and international standards (e.g. NEC, CEC, NFPA, ASTM, IEEE, ANSI, ISO, EN, etc.), as well as, Disney standards. (preferred)
AutoCad (desired)
Minimum BS in Software, Mechanical, Electrical or Physics

Design Assurance Engineer Resume Examples & Samples

Design and execute product assurance programs to effectively develop and approve new products
Prepare, review and analyse design history documents to assure technical accuracy, completeness and compliance with applicable internal, regulatory and customer guidelines. Ensure accurate and complete design records are maintained
Prepare validations, verifications, risk analysis documents and similar product assurance activities
Ensure test methods are in place to meet design specifications, customer requirement specifications and any required standards
Develop and validate new test methods and / or measurement equipment
Coordinate and carry out technical assignments
Support and conform to departmental systems and procedures, operating budgets and controls
Compile and prepare technical information for Regulatory Affairs for distribution to customers and regulatory authorities
Provide quality engineering support for pilot, pre-production and production lines
Keep informed of developments pertaining to engineering through contact with educational institutions and professional societies and perusal of trade and professional journals, texts and periodicals
Participate in programs directed toward improvement of employee skills and abilities
Maintenance of test lab including
Product benchmark testing to design file results and for competitor comparison testing
Failure investigation activities (internal and FER issues). Including interaction with the customer where needed to support better communication and feedback
Provide assistance with any approval equipment issues
Project management using standard Lake Region methodology
Assist in training employees in new or improved test methods
College graduate with degree in engineering. Alternatively, a combination of education, demonstrated skills and directly related experience equivalent to two years for each year of formal education
Knowledge of engineering theories and methods
General knowledge of medical device regulatory requirements including FDA, ISO, DOH and similar
Excellent written and verbal communication skills. Good presentation skills

Design Assurance Engineer Resume Examples & Samples

Identifies and resolves complex exceptions to work assignments
Summarizes, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings
Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product
Participates in Customer Complaints investigation for areas under their control
Continually seeks to drive improvements in product and process quality
Knowledgeable on QSR and ISO/MDD standards, constantly promoting awareness of best industry practices, making appropriate decision on a daily basis utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decisions
Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints
Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects
Knowledgeable on Risk Management, BSEN 14971 requirements
Compiles and analyses operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes
May participate directly in a new product/technology transfer to ensure compliance to all internal and regulatory requirements
Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality
Gives technical guidance to Associate Quality Engineer, Technician and Inspection staff
Is a good team member, fully motivated to achieve and demonstrate best practices in line with the department and Site objectives
Deals with suppliers, other engineering disciplines within and outside of the Site and customers should the need arise
Is familiar with the internal auditing process
HETAC Level 8 qualification in a relevant area with a min. of 3 years relevant experience
Good technical capabilities, communication skills, teamwork abilities and initiative
Proven ability to work well both as part of a team but also able to work on own with minimum supervision

Design Assurance Engineer Resume Examples & Samples

Works within a development team to identify and implement effective controls to support the development, qualification, and commercialization of products to meet or exceed internal and external requirements
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
BS in Engineering (Mechanical or Biomedical preferred)
0-2 years of experience
Medical Device experience preferred (internship experience accepted)
Mechanical aptitude with previous experience on mechanical test method validation
Knowledge of statistics (course work is acceptable)
Knowledge of Design Control and related deliverables and Risk Management
Strategic thinking with ability to execute on specific deliverables such as product design verifications/validation, failure analysis, etc
Problem solver with the knowledge and ability to facilitate the problem solving process

Senior Design Assurance Engineer Resume Examples & Samples

Provides leadership role on championing departmental or cross-functional engineering initiatives. Partners closely with R&D, Project Management, Regulatory, and Operations to develop smart technical solutions
Provides project direction, coaching, and mentoring for engineering and technical team personnel
Leads Risk Management activities for effective product development
Lead in the testing and validation of new designs to meet or exceed internal and external requirements
Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices
Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues
Mentor for technical guidance for identifying and resolving quality issues
Bachelor’s degree in Engineering and 5-8 years of experience or Master’s degree and 3-6 years of experience
Medical device industry preferred

Design Assurance Engineer Resume Examples & Samples

The stakeholder requirements are fully understood (within the context of the train design)
The train design is demonstrably compliant with contractual and legal requirements
The train gains necessary authorization to operate in passenger service
Reviewing customer technical specifications and legislation to understand requirements and consequently assisting vehicle engineers in making key decisions regarding vehicle concept and architecture to ensure that these requirements are met
Generating the necessary technical documentation in response to customer Invitations To Tender (ITTs) and leading the resolution of technical compliance issues relating to the train design during bid negotiations
Capture (and where necessary further develop) customer and regulatory requirements based on contractual and tender documentation and assist the cascade of these requirements with appropriate verification activities to systems within the train (in DOORS)
Liaison with the engineering team to determine and support development of verification evidence necessary to gain design conformance (both customer and regulatory)
Planning and estimating timescales and costs associated with delivery of the scope of work associated with the role. And directly managing the scope of work during bids and projects
Engineering Degree
Master’s Degree (desirable)
System Integration and System Architectural understanding
Rail experience desirable
Significant experience and hands on delivery of the design, analysis, development, testing and delivery of engineering solutions that solve complex requirements
Provide technical expertise in Requirements Management, Design verification and Authorisation (in at least one area – essential)
DOORS experience (desirable)
Be able to demonstrate the ability to use this technical knowledge in the support of other departments (engineering, production, procurement, projects) and the development of less experienced engineering personnel
Very good leadership skills; Acts as a resource for colleagues with less experience; may direct the work of other staff members
Demonstrates excellent communication skills and the ability to communicate across a wide group of audiences – engineering communities, customers (internal & external), senior management
Demonstrable ability to solve complex problems; analyse possible solutions using technical experience and judgement

Principal Design Assurance Engineer Resume Examples & Samples

10+ years of relevant engineering experience including 5+ years of reliability testing and analysis of cardiovascular devices
Effective negotiation and influencing skills
Experience with Tissue valve development and manufacturing
DFLS/Six Sigma/ DRM Experience
An understanding of clinical/technical applications of cardiovascular products and human anatomy
Working knowledge of FEA simulation tools and analysis
Strong statistics background
Understanding of clinical/technical applications of cardiovascular products and human anatomy
Biomaterials ( metals and polymers) knowledge and analytical characterization tools
GMP, QSR, ISO 13485, ISO 14971 experience
Ability to effectively manage multiple competing priorities

Senior Design Assurance Engineer Resume Examples & Samples

MS in Science, Mechanical or Biomedical Engineering
4+ years of relevant engineering experience including reliability testing and analysis of cardiovascular devices
Experience with Catheter based delivery systems development and manufacturing
Experience with Coronary and Cardiac implantable devices
Certified Quality Engineer (CQE)/Certified Reliability Engineer (CRE)
Minitab experience
Experience with GMP, QSR, ISO 13485, ISO 14971
Extensive experience with reliability testing and analysis of in particular cardiac implantable devices, life sustaining cardiovascular devices

Senior Design Assurance Engineer Resume Examples & Samples

BS in Engineering or Science
5+ years of experience in regulated environment
BS in Electrical, Computer/Software, or Biomedical Engineering. Other engineering fields with software engineering focus acceptable, if experience demonstrates proficiency in hardware/software development
Working knowledge of ISO quality system (ISO13485), USFDA Quality System Regulation, 21 CFR Part 11 compliance, and relevant international standards
Working knowledge of C and object-oriented programming (Java, C++, etc.), scripting languages (e.g., Python, PERL, Shell), and LabView
Knowledge of Minitab desired
Knowledge in electrical and electronic manufacturing processes as they apply to the design process
Previous experience with process qualifications
Previous experience with product impact assessments and CAPAs
Skilled in project leadership practices including ability to balance risk, effectively influence diverse teams, and ownership of responsibility for outcomes
Working knowledge of Lean, Six Sigma, or Design for Reliability and Manufacturing
Electrical, Computer/Software, or Biomedical Engineering degree
Hands on experience in dFMEA, pFMEA, risk analysis and management
Medical device development knowledge, including V&V activities and direct V&V protocol development
Experience with embedded microprocessor controlled equipment development
Expert knowledge of modern, iterative software design processes and development practices including agile and test-driven development
Experience with test station design and development
Highly motivated hands-on engineer with a proven record of meeting timelines and goals
Must possess strong analytical & problem solving skills
Excellent judgment and strong critical thinking skills
Demonstrated ability to build effective relationships across organizations and geographies
Working knowledge of IEC60601 and familiarity with IEC 62304 and other relevant medical device standards
Proficient with Microsoft Excel, Word, PowerPoint, & Project
Experience with requirements management, version control, and issue tracking tools
Experience working with remote facilities, both domestic and international
Formal training in software development & validation processes

Senior Design Assurance Engineer Resume Examples & Samples

BS in Electrical, Computer/Software, or Biomedical Engineering. Other engineering fields with electrical engineering focus acceptable, if experience demonstrates proficiency in hardware/software development
Experience with sustaining engineering and change impact analysis
Experience with servicing of capital equipment
Working knowledge of Quality System Regulations (QSR), design control systems, ISO 13485 and GMP
Experience in Medical Device industry and Design Assurance
Knowledge in electrical and electronic manufacturing processes
Experience with SAP and/or ServiceMax

Principal Design Assurance Engineer Resume Examples & Samples

7 + years medical device engineering experience with Bachelor’s Degree in science or engineering OR 5 + years with Master’s Degree
Direct experience with 21CFR Part 820 and ISO 13485 and Quality system requirements in other geographies
5+ years of experience with medical device product development, design verification/validation, risk management, reliability engineering, process validation and Quality systems
5+ years of experience with relevant ISO and FDA regulations and Good Manufacturing Practices (GMP)
MS in Engineering, Bioengineering, or Biotechnology is a plus
ASQ Certified Quality Engineer or Six Sigma Black Belt is a plus
Internationally certified quality auditor designation is a plus
Project Management Professional (PMP) certification is a plus
FMECA and risk management
Design Control
Protocol generation and execution
Statistics, statistical tools and software, for utilizing such tools as DOE, ANOVA,
Confidence and Tolerance Limits, Gage R&R, SPC
Six Sigma Methodology
Experience with medical device products
ISO 13485 and 14971, FDA CFR 21 part 820 requirements
Microsoft office (Word, Excel, PowerPoint, Visio)

Senior Design Assurance Engineer Resume Examples & Samples

Actively participate on new product development projects ensuring that product design inputs are clear, concise, testable and appropriate and that design outputs confirm compliance to the design inputs
Participate in product risk assessment efforts, including hazard analysis and design failure mode effect analysis, within product teams and updates to existing product lines
Review and approve design verification and validation test plans, protocols and reports. Ensure V&V results demonstrate compliance to medical device standards
Review test methods for quality of verification and validation of the method
Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation, ISO 13485 Regulations, and other applicable standards
Participate in continuous improvement of design control process and project management planning
Skilled in requirements analysis, including testable and measurable specifications
Experience with test methods and standards for the design, verification, and validation of medical device products
Skilled in test plan development and root cause failure analysis
Familiar with reliability analysis and test methods and test method validation
Working knowledge of IEC60601, IEC62366, EN62304
Good verbal (including presentation) and written communication skills, especially technical report writing
Ability to effectively work on project teams
Ability to appropriately assess written design and device documentation as the principle advocate for compliance
Working knowledge of the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive
Working knowledge with ISO 14971, experience in risk evaluation techniques, such as FMEA, fault tree analysis or HACCP
Skilled in statistical methods and design of experiments
Manufacturing engineering or manufacturing quality engineering experiences a plus
3-5 years of engineering experience, preferably with V&V system/software validation
Strong working knowledge of verification and validation in a regulated industry

Senior Design Assurance Engineer Resume Examples & Samples

Familiar with ISO 14971, experience in risk evaluation techniques, such as FMEA, fault tree analysis or HACCP
4-6 years of engineering experience, preferably with capital equipment including V&V system/software validation
Working knowledge of verification and validation in a regulated industry
Working knowledge of risk management for medical device products

Design Assurance Engineer Resume Examples & Samples

Support test method validation studies and statistical analysis of testing methods for both design and in process systems
Experience with medical camera inserts used in laser surgical cases
Support reprocessing studies compliant to TIR 12, 30, and FDA reprocessing guidance
Be able to logically apply relevant statistical models to compare R&R data to specifications in determining fitness of test method(s)
Participates in project teams to review and develop clear and concise user requirements, product specifications, plans, verification and validation studies, risk management file and other relevant design control deliverables
Able to lead and drive creation of Design or Process FMEA with relevant cross functional teams in mimizing redundant efforts. Apply engineering principles to draft failure and representative clinical effects
Have biomedical exposure and knowledge in performing representative risk analysis and hazard identification. Influencing R&D teams to prioritize safety and efficacy failure models with design mitigations through balanced approaches
Continously improve risk management files and trending analysis through Risk Management reports, PMSR, or other revelevant documenatation tools
Ability to understand the correlation between reprocessing testing criteria to design or reprocessing instruction considerations
Support Software Risk Management per ISO14971
Support/Review Storage and transport studies per ISTA 2A,B, or other relevant ASTM standards
Support Human Factor studies to ensure device's use errors are minimized or mitigated through standardized approach in conforming to IEC 62366, or AAMI HE75
Able to be the bridge between R&D team and labeling group to ensure reprocessing and other product label conforms to relevant requirements, standards and regulations
Ensures requirements and specification are captured adequately in verification, validation, and relevant qualification studies
Ability to understand and interpret mechanical, optical, biological specifications or requirements to ensure traceability
Supports FDA/QSR requirements by assisting and reviewing design control deliverables
Ensure effective design transfer to process development team
Influences and defines functional, departmental/divisional procedures through involvement with cross-functional engineering initiatives
Must have engineering undegradate degree (Biomedical Engineering preferred)
Experience with Boston Scientific's Quality and Business Systems

Design Assurance Engineer Resume Examples & Samples

Provide design assurance activities, reviewing contractors’ designs and NEC-3 Project Manager’s acceptance of contractors’ designs for the Main Work Contracts
Mitigate engineering risks with a thorough understanding of responsibilities under the CDM regulations (2015). Participation in design review workshops (including SWIFT, HAZOP, OPMAN and Interdisciplinary Reviews)
Maximising quality and value of design while minimising the project risk profile
Coordinate engineering activities with other team members and cross-project engineering functions
Contributing to the co-ordination and integration of the engineering designs with the overall system requirements and disciplines, such as tunnelling, existing TW and third-party infrastructure, geology, hydraulics and modelling, mechanical, electrical, control and instrumentation, architecture, landscape, operations, planning, environment, property, security, community, communications etc
Support, review and challenge design development including leading on evaluation and reviews
Managing/supporting the design process, including monitoring, control and reporting against budget, forecast, progress, schedule and deliverables and contributing to the design risk registers
Work with the Engineering Manager to resolve any existing or forecast problems related to discipline, quality of work, schedule performance or productivity
Eligibility to work in the EU
Degree in Engineering
Chartered Engineer or near Chartered - AMICE / MICE - Desirable
Member of an appropriate professional institution
Grounding in design delivery of tunnel and sewerage projects within the UK
Understanding of hydraulics and experience in design of hydraulic structures and control mechanisms associated with sewerage infrastructure projects within the UK, particularly, the design of CSO’s and/or deep storm sewers/wastewater pumping stations
Understanding of design and construction of heavy civil engineering within a dense urban environment including deep-shaft construction, diaphragm walls, embedded retaining walls and knowledge of how these relate to bored tunnelling activities
Knowledge of working as designer / coordinator / reviewer within Project Management team overseeing construction / and administering the contract
Understanding of quality assurance of design deliverables

Principal Design Assurance Engineer Resume Examples & Samples

Possesses working knowledge of FDA Quality System Regulations, 21 CFR 820 Part 11, ISO 13485, ISO 9001, and the Medical Device Directive
Possesses working knowledge of Risk Management, ISO 14971, Hazard Analysis, Failure Mode Effects and Criticality Analysis (FMECA)
Familiar with Medical Device Software Life Cycle Processes, IEC 62304
Familiar with Medical Electrical Equipment, IEC 60601
Competent in the development of concise, unambiguous, and feasible product requirements
Competent in Process Validation (IQ, OQ, PQ), Control Plans, DOE, Statistical Process Control and Capability Analysis
Competent in Verification and Validation protocol development and report generation
Competent in Process Improvement and Correction and Preventative Action (CAPA)
Competent in Statistical Techniques, Sampling Plans, Measurement System Analysis, Confidence Levels, Hypothesis Testing, ANOVA, Parametric and Non-parametric Analysis
BS in Engineering or similar related technical field
8+ years of new product development quality engineering experience in the medical device industry
5+ years of new product development quality engineering experience in the medical device industry with a MS in Engineering or similar related technical field
3+ years of new product development quality engineering experience in the medical device industry with a PhD in Engineering or similar related technical field
Previous experience working in a regulated or medical device development environment
Previous experience working in a cross-functional team environment
ASQ CQE, CQA, CSQE and/or CRE certification
Formal green belt or black belt training in Lean and/or Six Sigma methods
Familiar with statistical software tools such as (Minitab, Stat Graphics, Statistica or Jump)
Familiar with Stability, Biocompatibility, Sterilization, Ship Testing, HALT/HASS
Interpersonal and oral/written communication skills

Senior Design Assurance Engineer Resume Examples & Samples

Review new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, biocompatibility, sterility, and conformance to product requirements
Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation, ISO 13485 regulations, ISO 14971 risk management standards, Medical Device Directive, and other applicable standards
Utilize risk evaluation techniques, including FMEA, fault tree analysis and HACCP
Ensure successful transfer of new products to production facility
Review production processes for quality of verification and validation methods
Review and approve verification and validation test methods, test plans, standards for the design, and verification and validation of medical device products
Ensure verification results demonstrate compliance to medical device standards
Develop test plans and perform root cause failure analysis
Lead project teams with verification/validation statistical methods and design controls
Participate in product risk assessment efforts within product teams and updates to existing product lines
Review statistical methods statistical process control, sampling plans, gauge R&R and design of experiments
Travel to various and unanticipated locations within the United States and to the Hologic facility in Costa Rica three times a year

Senior Design Assurance Engineer Resume Examples & Samples

Responsible for participating in design and development projects and assuring the design process meets all requirements
Responsible for reviewing design drawings for tolerance, inspect-ability and quality of design issues
Work with suppliers to improve quality and assist, where necessary, in supplier process validations
Train and/or assist QC Manager in the training of QC Inspectors on inspection techniques and the use of new equipment
Participate in Internal and External quality audits as directed by the Quality Assurance Manager
Responsible for assisting in the design and development of methods and tooling for the test and inspection of articles
Responsible for assisting in maintaining vendor files in accordance with established procedures and SOPs
Responsible for writing and/or assisting in the writing of test and inspection SOPs
Responsible for assisting in complaint investigations as related to product quality
Responsible for assisting in compiling and reporting on Vendor performance statistics
Responsible for filling in for absent QC technicians and the Document Control Specialist as directed by the QA Manager

Senior Design Assurance Engineer Resume Examples & Samples

As a Product Development Core Team member, proactively influence designs to achieve product quality and reliability targets that meet or exceed customer expectations
Develops or participates in establishing requirements for all verification and validation activities
This role is based in Orange Ca, and works within a cross-functional, matrixed global organization to drive dynamic performance in all areas
Working knowledge of Minitab and tools such as Design of Experiments, Process Capability Studies, Failure Mode and Effects Analysis, Statistical Process Control, Industrial Statistical Methods and Lean Manufacturing
Working knowledge and experience with global medical device regulatory requirements and product development process.Familiarity with CAD/CAM systems or other computer aided manufacturing systems
Familiarity with CAD/CAM systems or other computer aided manufacturing systems is a plus
American Society for Quality certification desired

Design Assurance Engineer Resume Examples & Samples

Actively participates in defining customer requirement, product claims and target markets early in the product development lifecycle
Lead/assist on complex technical problems where analysis of situations or data requires an in-depth evaluation of various factors and solve a wide range of difficult problems in creative and effective ways
Apply state-of-the-art inspection and quality engineering/assurance techniques, procedures, instruments, equipment, theories, principles and concepts to products and processes
Leads development of Risk Management documentation
Leads/participates in data collection, analysis, trending and reporting on non-conformances and investigations to determine root cause, corrective and preventive actions
Participates in audits and inspections of the company and our quality systems
Knowledge and experience with global medical device regulatory requirements and product development process
Ability to apply and integrate knowledge of other related engineering areas to own areas of expertise
Working knowledge and experience with EPA requirements and standards is strongly preferred
American Society for Quality certification

Senior Design Assurance Engineer Resume Examples & Samples

A seasoned, experienced professional with a full understanding of design control process; resolves a wide range of issues in creative ways
Responsible for assuring projects meet customer expectations, and regulatory requirements
Provide guidance to engineering staff and other personnel and ensure that design control requirements are being met in an effective manner, including those for design verification, validation, specification and procedure development, risk management, and design review
Provides input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested. Review DHF for accuracy and completeness and provide guidance on FDA compliance and procedures
Create processes and process improvements to ensure consistent implementation of internal requirements and external regulations and standards
Represent the design quality functions for the review and approval of designated deliverables
Assist in the development and maintenance of company procedures for design control, change management, risk management, test method validation, process validation and related areas of the quality management system
Represent the design quality assurance department to FDA, ISO and all other auditors as needed
Work independently on high visibility new product development projects; including projects involving multiple technologies and design sites
Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices
May escalate issues to supervisor/manager for resolution, as deemed necessary
Assist with various projects as assigned by a direct supervisor
Ability to life and/or move up to 50 lbs. with assistance
5 – 8 years’ related experience; or a Master’s degree with 3 years’ experience; or a PhD without experience; or equivalent directly related work experience
Familiar with critical elements of the design history file including risk management, design verification and validation tests and ensuring compliance of these elements to procedural requirements
Ability to multi-task and operate within a fast-paced environment
Strong organizational and presentation skills required
Excellent oral, written, analytical, computer and interpersonal skills

Design Assurance Engineer Resume Examples & Samples

You will investigate and resolve complaint trend and design issues
You will conduct Root Cause Analysis of product non-conformances as discovered by Manufacturing and Customers
Provide input to Process and Product Validations and new Equipment Qualifications
Lead or participate in the implementation of design improvements, product cost improvements, and CAPAs designed to meet or exceed internal and external requirements
Assure the development and execution of streamlined business systems which effectively identify and resolve quality issues
You may participate in Product Development, Design Review, and Design Control Activities and have direct input in design verification activities and planning
Prefer experience working with Single Use devices
Knowledge of Design Control and Risk Management

Senior Design Assurance Engineer Resume Examples & Samples

Leads or participates in the implementation of new product design (NPD) design assurance: Risk management (per ISO 14971), User and Design FMEAs, requirements traceability matrices, design verification and validation, Design Change Analysis Forms, etc. Utilize statistical analysis techniques to determine product acceptance
Leads or participates in core team meetings, CCB, and MRB meetings. Interfaces and manages work with other quality organizations such as biocompatibility, microbiology, sterility, and manufacturing/ops requirements. Thorough understanding of design controls
Participates in design reviews, design transfers, and in all aspects of the Design Control process for the PCI Guidance products. Ensure customer requirements are met by incorporating engineering principals in robust design and in design for manufacturability. Actively participate in all aspects of Design Control
Design, develop, refine, and validate test methods and inspection procedures. Guide/author design verification and design validation protocols and reports
Fully support the Quality Policy by building quality into all aspects of the incumbent's work and by maintaining compliance to all quality requirements (including but not limited to being current on all training requirements for the incumbent's position and documenting that training)
Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
Lead and participate in product failure investigations and root cause analysis
Provide technical guidance and training to team members in statistical analysis techniques, experimental design and other QA Engineering areas of expertise
Provide technical guidance and training to other department members and engineering staff in statistical analysis techniques, experimental design, data analysis, and product/process verification and validation
Directly interface with people performing internal and external audits
Interface with agents of regulatory bodies as necessary to demonstrate quality system compliance. Support certification / recertification activities for US, European and other markets
Consult with and provide guidance to Quality Technicians and other Quality Engineers. Work to ensure compliance with corporate quality systems requirements
Provides leadership role on championing departmental or cross-functional engineering initiatives
Proactively investigates, identifies, and implements best-in-class Quality Engineering practices
Understanding of technologies incorporated into design
5-8 Years of related experience with Bachelor’s Engineering degree, 3-6 Years with Master’s Engineering
Understanding of electrical safety standards IEC 60601
Experience with reliability testing
Understanding of configuration management
Demonstrated used of Quality tools/methodologies
Previous R&D experience
Strong knowledge of QSR and ISO standards
BS in Electrical Engineering preferred
1-3 years medical device experience
ASQ certification a plus

Senior Design Assurance Engineer Resume Examples & Samples

Drive Design Assurance support and oversight for product development activities
Ensure product development team(s) follow critical procedures & processes
Ensure risk management tools are employed and evolving (HARA, DFMEA, PFMEA) Oversee and ensure risk assessments adequately address safety and efficacy and are compliant to the highest standards. Promote a “safe culture”
Ensure requirements traceability and flow from customer requirements into L1/L2 specs
Ensure design targets, guidelines, specifications & standards exist and are adhered too
Ensure validation targets, pass/fail criteria & procedures exist and are adhered too
Perform independent assessments of new product development programs
Establish standard work for design process assessments & adherence
Ensure compilation, storage & reuse of critical design history documentation
Ensure robust, proactive design reviews by leveraging standard work & best practices
Ensure post sales assessments are conducted & lessons learned part of future programs
Review and approve critical design process milestones
BS Degree in Mechanical or Electrical Engineering or equivalent. MS degree preferred
Minimum 7 years of experience in product development and/or product quality roles
Strong acumen for industry best practices in development, testing & manufacturing
Experience in establishing and implementing quality metrics for product development
Extensive use of the Microsoft Office suite. Experienced with PPT & Excel
Strong communications skills, problem-solving & ability to influence required

Senior Design Assurance Engineer Resume Examples & Samples

Represent the Quality function on product and process development project teams. Actively support and engage in design reviews and manufacturing transfer reviews
Lead or support design activities including design verification, validation, specification setting and justification, test method development, and risk management
Serve as a Site Quality Representative for the TMVR Venture. Maintain site QA Agreements, support biannual TMVR QMR, support all TMVR internal and external audits. May lead site TMVR CAPA and NCMRs
Ensure Twelve QMS compliance and support activities to prepare the QMS for commercialization for the Intrepid Mitral Replacement System
Support the integration of the TMVR Venture to the HVT business unit
Evaluates biocompatibility, sterility, and pre-clinical test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives
Provides input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested
Develop and implement both manufacturing and design verification test methods
Promotes continuous improvement in design control activities and use of quality tools with design team
Participates in supplier selection process and specification reviews with suppliers to ensure that purchased items meet Medtronic specifications
Specifies quality characteristics and inspection plans for components, subassemblies, and finished devices
Comply with applicable FDA and international regulatory laws/standards and the Medtronic of Conduct
Other duties as assigned or required
Bachelor’s Degree in Engineering or Science (Life Sciences, Physics, ME, EE, Industrial Technology, etc.)
4+ years (with Bachelor's) or 2+ years (with Master's) of related experience
Experience in the Medical Device Industry
Working knowledge in ISO13485 and ISO14971
Master’s Degree
Master’s Degree in Engineering or Science (Life Sciences, ME, EE, Industrial technology, etc.)
Experience with structural heart devices and/or catheter based devices
Self-motivated and committed to a small, focused team approach
Strong interpersonal, organizational, and project management skills
Strong oral communicator and technical writing skills
General knowledge of ISO 5840-3
Demonstrated ability to be adaptable
Extensive knowledge of quality tools
Risk management
Highly proficient in math and use of statistical techniques
Six sigma
Lean principles
Root cause analysis
Problem solving approaches
Reading and correcting drawings
Project management methods and tools
Quality System Regulation (QSR)
Medical Device Directives (MDD)
FDA requirements and guidance
Good Manufacturing Practices (GMP)
Good Laboratory Practices (GLP)
Use of various tools, including microscopes, calipers, and other inspection equipment
Knowledge of sampling methods
While performing the duties of this job, the employee is regularly required to be independently mobile
May be required to travel frequently to Redwood City, CA during on boarding

Senior Design Assurance Engineer Resume Examples & Samples

Integral member of product development team responsible for leading activities required to ensure reliability of the design. Work closely with product development engineering, clinical, marketing and regulatory to assure appropriate reliability requirements are defined for the specific device application and target patient population
Facilitate trade-off studies and design sensitivity analyses to identify reliability-critical design variables
In collaboration with product development, formalize new testing methodologies and approaches required to complete comprehensive reliability analyses of device designs. Lead verification and validation activities for newly developed test methods. Must be "hands on" when leading the development and validation of functional test methods
Direct completion of specific product verification/validation testing and analyses required to satisfy both regulatory and internal Medtronic requirements, including the preparation of high quality plans and technical reports
Work directly with product development engineering to translate user requirements into design requirements down to the component level. Provide support for the identification of critical components and design features
Leads risk management activities throughout the product life cycle, including Product Hazard Analyses, DFMECAs, PFMECAs, and UFMECAs
Work with product development engineering and manufacturing engineering to translate design requirements into manufacturing requirements to achieve design for manufacturability. Provide guidance for development of manufacturing test/evaluation methods to assure process reliability requirements are attained
Serve as a technical resource for problem investigations to guide root cause analysis / corrective action development
Provides technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, and practicable, and consistent with organization objectives
Coordinate the preparation and design of high quality presentation materials summarizing results of reliability assessments. Must be able to confidently present results to the customer or company management
Provide clear and regular technical and administrative direction to professional, technical and administrative personnel assigned to a project. Requires broad perspective of company, regulatory and divisional policies in addition to personal representation and leadership abilities
Facilitate and lead design and reliability activities related to Design, Manufacturability, and Reliability (DRM) practices. This includes planning, leading, facilitating, and supporting activities such as robust engineering, reliability predictions, capability analysis, development of CTQ's, VOC, requirements flow down, etc

Senior Design Assurance Engineer Resume Examples & Samples

Plans, conducts and executes design assurance activities requiring judgment in the independent evaluation, selection and the substantial adaptation of standard mechanical engineering techniques, testing procedures and criteria
Works closely with design, development, quality, regulatory, and the client team to establish and document the master verification plan in conformance with the system design specification and sound testing principles
Plans, coordinates and executes design verification testing to directly support the master verification plan
Participates with the engineering team to establish and review the design FMEA
Possesses a comprehensive understanding of ISO10555 principles, design FMEA practices, and any industry standards to ensure products satisfy all ISO 13485 requirements
Support various QA/RA activities including quality management, system reviews, audits, etc
Support risk management activities
Evaluation of new products, assuring the safety and efficacy of the devices
Design verification and shelf life protocols / reports review
Clear present information to Regulatory Affairs to minimize Regulatory Agency questions
Support customer complaint analysis and post market surveillance activities

Senior Software Design Assurance Engineer Resume Examples & Samples

5 – 8 years of Medical Device experience along with a BS in Engineering or related discipline
Capital equipment and software development product experience
Knowledge of 62304 and/or Software Development Life Cycle
Knowledge of Design Controls and Risk Management
Able to see the big picture, but also able to execute on specific deliverables such as product design verifications/validation, failure analysis and bring them to closure
Problem solver with the knowledge of problem solving tools, capable of facilitating problem solving process
Works well on a team and able to influence decisions of others
Familiarity with BSC Quality System

Design Assurance Engineer Resume Examples & Samples

Participate in the establishment of medical device user needs and intended uses that are necessary and appropriate
Participate in establishing medical device design requirements, ensuring they are complete, unambiguous and testable
Perform and manage design verification and validation activities (in house and with external partners)
Develop and execute test methods
Support the development and maintenance of the risk management file
Support the review of and make updates as required for labeling while ensuring compliance with FDA UDI requirements
Technical writing in support of design inputs, design outputs, qualification activities, regulatory requirements and related pursuits
Support and review the creation and maintenance of DHF’s, Technical Files and similar documents
Participate in assigned medical device development projects with primary influence on design assurance activities
Participate in medical device design reviews as participant and independent reviewer, as applicable
Microsoft Office Proficient (Word, Excel, Access, Visio and Outlook)
Proficient in PLM/ERP (including document and change control)
Proficient in analytical packages (MiniTab, Mathmatica, etc)
Experience and understanding of 21 CFR 820, ISO 9001, ISO 13485 and related quality system requirements for medical devices
Experience with and understand of ISO 15223, ISO 14971, IEC 60601, IEC 62304, IEC 62366, ISO 10993, ISO 14644 and USP/EP standards
Prior Descriptive Statistics and Hypothesis Testing (i.e. t-test, f-test, ANOVA)

Associate Design Assurance Engineer Resume Examples & Samples

Provide Design Assurance Engineering (DAE) and technical quality support to project teams in the Product Development Process or in support of post market changes
Provide support and / or execute quality deliverables required by the Product Development Process, Post Market Change Process or Supplier Change Control Process
Prepare and / or support the creation of design verification test protocols and reports
Support the execution of all design verification and validation activities including the overseeing testing. Coordinate with all supporting functions (e.g. Test Lab, Microbiology, etc.) to meet project milestones
Support the execution of all design verification and validation activities, including the determination of statistically relevant sample sizes
Serve as a quality extended team member on new product development project teams or post market change teams
Participate in risk management activities including the creation of the preliminary hazard analysis, Design-FMECA, Post Market Surveillance (PMS) Reports and support risk management document changes due to post market quality activities (PEC, PIA etc)
Identify and understand design related product failure modes
Assure all applicable quality decisions are derived from the appropriate risk management document in accordance to the quality system
Support R&D, Operations, Regulatory Affairs and Component Engineering during all product development phases
Support the pilot manufacturing line by performing Quality Review and NCMR support
Provide support for the creation of design control documents, such as specification documents, process instructions, and receiving inspection documents
Support cross functional pre and post-market root cause analysis teams
Support design reviews for pre and post market projects
Support preparation of design dossier and regulatory submissions
Support the Quality System to achieve FDA facility registration and ISO certification / CE marking
2+ years of similar experience
Experience working with medical devices or in a highly regulated environment
The employee is also required to interact with a computer for extended periods of time, and communicate with peers and co-workers
Required to sit or stand for extended periods of time
Required to do light lifting up to 25 lbs

Senior Design Assurance Engineer Resume Examples & Samples

Execute quality deliverables required by the Product Development Process, Post Market Change Process, or Supplier Change Control Process
Support the execution of all design verification and validation activities including overseeing testing. Coordinate with all supporting functions (e.g. Test Lab, Microbiology, etc.) to meet project milestones
Lead all design verification and validation activities, including the determination of statistically relevant sample sizes
Serve as a quality extended team member or core team member on new product development project teams or post market change teams
Lead risk management activities including the creation of the preliminary hazard analysis, Design-FMECA, Post Market Surveillance (PMS) Reports, and support risk management document changes
Partner with R&D, Operations, Regulatory Affairs, and Component Engineering during all product development phases
Support pilot manufacturing line by performing Quality Review and NCMR support
Support development and validation of clinically relevant test methods
Monitor design capability metrics to assure design robustness
Communicate any quality related problems and issues to DAE / QA management, support the remedial, corrective and preventative actions and ensure closure of the problem / issue
Support preparation of design dossier and regulatory submissions. Interface with Regulatory Affairs to ensure information is clearly presented to minimize Regulatory Agency questions
Have a solid understanding of compliance regulations and requirements
May provide quality support to pilot manufacturing operations, quality initiatives, and support production quality issues resolution
May perform validations to implement new tests and / or test equipment
May support CAPA’s and audit’s (internal and external)
May make updates and improvements to the test & inspection methods, inspection forms, and related documentation used to evaluate product functionality and quality
May support customer complaint analysis and complaint trending
May support Product Impact Assessments
May support Product Evaluation Committees
Provide support to more junior level DAE engineers
Bachelor’s Degree in Engineering, Bio-engineering or other technical discipline
4+ years (with Bachelor's) of similar work experience
3 years of experience in the medical device industry
Experience with medical device product and or process risk management
Experience with developing new products or supporting commercial activities for class 3 medical devices
Experience with medical device regulations and standards such as ISO 13485 and CFR 21 Part 820
Proficient with statistics, statistical tools, and software
Experience with process Development, Characterization, and Validation
Experience with process improvement tools (i.e. Lean Manufacturing and Six Sigma)
Experience utilizing Microsoft office (Word, Excel, PowerPoint, Visio)
Experience with Solid Works
Master’s Degree in Engineering, Bioengineering, or Biotechnology
ASQ Certified Quality Engineer or Six Sigma Black Belt a plus
Internationally certified quality auditor designation a plus
Experience and or knowledge in drug combination products
Experience with combination drug/medical device products preferred
Ability to solve very complex problems that require creativity
Ability to deliver on multiple projects simultaneously
Ability for reasoning and logical deduction
Ability to shift between abstract and concrete concepts
Excellent prioritization and verbal/written skills
Strong collaboration skills
Must be able to do light lifting, up to 25 lbs

Senior Design Assurance Engineer Resume Examples & Samples

Provides leadership role on championing departmental or cross-functional engineering initiatives. Key projects include design change; design verification test planning, execution, and reporting; CAPA; and product risk management
Leads in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues
5-8 years of experience with BS in Biomedical, Engineering, Quality or related discipline OR 3-6 years with Master's degree
Medical Device experience or other highly regulated industry
Knowledge of Project Management
Knowledge of Design Control, knows linkages between deliverables
Knowledge of Usability tools
Knowledge of Risk Management
Able to see the big picture, but also able to execute on specific deliverables such as product design verifications/validation, failure analysis
Root cause investigation skillset
Test method validation experience
Excellent written and verbal communication
Ability to prioritize effectively
Works well on the team
Able to influence decisions of others

Senior Design Assurance Engineer Resume Examples & Samples

Adheres to Galvani’s Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements
As a quality Core Team member actively participates in development project teams. Performs quality/reliability engineering activities while providing guidance to ensure that the design/development procedures, design controls, supplier controls and test requirements are fulfilled
Leads Risk Management (ISO 14971) and Usability program activities. Leads cross function teams in planning, analyses (DFMEA, FTA, Risk / Benefit) and mitigations. Prepares required deliverables to execute and document the risk management outcomes, controls measures, residual risks in reports. Maintains risk management file for the life of the device
Lead packaging and sterilization validation per EN/ISO 11607 and ISO 11135 respectively
Coordinates with R&D in DAE review of technical documentation, develop test methods and prepare design verification and validation test deliverables. Plans and conducts compliance testing to recognized international standards
Coordinates with Process Development in review of test fixtures/ test methodology, develop production acceptance criteria, test methods, and process validation protocols
Provides support in supplier and internal auditing (DHF and Technical files for conformance), external lab qualification, technical standards interpretation, and appropriate statistical methods, including sample size determination
Provides support in conducting root cause analyses, preparation of CAPA and HHA. Draft and update SOPs
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