Senior Design Quality Engineer Resume Samples
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Senior Design Quality Engineer Resume Samples
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JG
J Goodwin
Jazlyn
Goodwin
45086 Bernier Ranch
Phoenix
AZ
+1 (555) 287 4921
45086 Bernier Ranch
Phoenix
AZ
Phone
p
+1 (555) 287 4921
Experience
Experience
Dallas, TX
Senior Design Quality Engineer
Dallas, TX
Schuppe, Paucek and Mitchell
Dallas, TX
Senior Design Quality Engineer
- Supports design test and inspection method development and validation
- Provide effective quality engineering support for new product transitions into commercial production
- Generate, review and approve Engineering and Development Change Orders for Design Assurance
- Take initiative to identify and drive improvements to the Illumina quality system
- Function as a quality lead on multiple product development teams in matters relating to Quality Engineering
- Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues
- Identify areas and opportunities to improve quality system processes
Chicago, IL
Senior Design & Quality Engineer
Chicago, IL
Ankunding and Sons
Chicago, IL
Senior Design & Quality Engineer
- Working knowledge of network routing, switching and security
- 8 years working as a Quality Engineer
- Expert knowledge of Linux and Microsoft operating systems
- Expert level user for Visio and or other similar design tools
- B.S. Computer Science
- Develops master test plans that encompass design verification, design validation and process validation activities
- Lead the investigation of complex product problems. Identify and manage corrective actions resulting from problem investigations
present
Los Angeles, CA
Senior Design Quality Engineer New Product Development
Los Angeles, CA
Buckridge LLC
present
Los Angeles, CA
Senior Design Quality Engineer New Product Development
present
- Product development team member focused on product development and life cycle management activities related to the Trauma/CMF business
- Support risk management activities including planning, design & clinical risk management, production risk management, and overall risk summary reporting
- Provide technical support and methods to assist production
- Enhance the design control and risk management processes to better reflect state of the art practices and drive continuous improvement
- Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
- Supports in the development and maintenance of Quality Management System procedures
- Trend, analyze, and report on quality data in order to improve product and process; develop recommendations based on data analysis
Education
Education
Bachelor’s Degree in Engineering
Bachelor’s Degree in Engineering
University of California, Santa Barbara
Bachelor’s Degree in Engineering
Skills
Skills
- Function as a quality lead on multiple product development teams in matters relating to Quality Engineering
- Positive attitude & good communication skills
- Lead investigation of quality issues and effective corrective and/or preventive action
- Self- starter, with the ability to work independently and with all levels of managers, associates, and clients
- Communicate at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing
- Certified Quality Auditor (CQA)
- Certified Quality Engineer (CQE)
- Good English Skill and Mandarin skills
- Familiar with IEC 60601, ISO 5361, ISO 5366 and product specific industry standards. Desirable
- Familiar with DMAIC or DMADV(DFSS) methodologies Desirable
15 Senior Design Quality Engineer resume templates
Read our complete resume writing guides
1
Senior Design Quality Engineer Resume Examples & Samples
- BS and/or MS in engineering or equivalent technical discipline required, and advanced degree preferred
- 6+ years of device and/or combination product development within a medical device or biotech or pharmaceutical organization required, including minimum of 2 in design quality, required
- Extensive knowledge of both US and International Design Control and Risk Management requirements (specifically 21 CFR Part 820, ISO 13485, ISO 14971), as well as other applicable standards required
- Experience in leading design quality activities required
- Experience with drug delivery injection systems required
2
Senior Design & Quality Engineer Resume Examples & Samples
- 8 years working as a Quality Engineer
- In depth understanding of Polycom core infrastructure and components
- Expert knowledge of Linux and Microsoft operating systems
- Understanding of coding and development principals. Development is not necessary but candidate must be able to communicate with developers at a programatic level and write development requirements
- Working knowledge of network routing, switching and security
- Excellent technical research and writing skills
- Expert level user for Visio and or other similar design tools
- B.S. Computer Science
3
Senior Design Quality Engineer Resume Examples & Samples
- BS. in Engineering or associated scientific discipline
- Minimum of 4 years medical device experience in Quality or R&D Engineering position with design control and product development experience
- Strong working knowledge of risk management, CAPA, and Design Controls
- Strong working knowledge of Medical Device Regulations, FDA Guidance Documents and Industry Standards
- Proficient with Minitab - Comparative Statistical techniques, sampling plans, GR&R, K-factor, hypothesis testing and ANOVA
- Reliability and Human Factors engineering experience
- ASQ CQE, CQA, CSQE and/or CRE certification (preferred)
- DFSS Black Belt (preferred)
- Agile (preferred)
- Experience working across geographies and working in a cross-functional team environment
- Excellent problem solving skills, including demonstrated application of structured problem solving methods and tools
- Demonstrated critical thinking skills with focus on improved system performance outcomes and positive business impact
- Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience)
- Strong collaboration and influence skills (build relationships, leverage others, align and work towards shared outcome-based goals, understand others’ needs, negotiate for win-win, own the whole)
- Proficient in Microsoft Word, Excel, Minitab and managing electronic data files
4
Senior Design Quality Engineer Resume Examples & Samples
- Good communication skills, both written and oral and must be computer literate
- Knowledge of or experience in developing and manufacturing medical devices in conformance with Quality System Regulations and ISO 13485 requirements
- Knowledge of analytical tools and methods, including statistics (Minitab preferred), DOE and the use of computer/software packages related to design, development and manufacturing
- Preferred Skills/Qualifications
- Minimum (7) seven years’ experience in design, manufacturing or quality engineering position (medical device experience preferred). Three years of experience can be substituted for an Advanced degree in a related discipline. Experience with analytical tools and methods, including statistics (Minitab preferred), DOE, and the use of computer software packages related to design, development and manufacturing. Statistical Quality Control/Statistical Process Control, Design of Experiments, Failure Mode and Effects Analysis. Experience in a regulated environment (FDA, ISO, etc.)
5
Senior Design Quality Engineer Resume Examples & Samples
- B.S. degree in Engineering or associated fields, or equivalent industry experience
- Knowledge and expertise in supply chain management and supplier development, stakeholder management, risk/issue management, implementation planning, training/communication, scope management
- Broad business knowledge and ability to link customer needs with business
- MS Office (Excel, PowerPoint, Outlook)
- Certified Quality Engineer (CQE) / Certified Quality Auditor (CQA) preferred
- MS Project, Minitab
- ASQ certification in Quality Engineering desirable
6
Senior Design Quality Engineer Resume Examples & Samples
- Minimum 5 years experience in Quality Assurance, including Quality systems, standards, metrics, and tools
- OpEx experience required: Six Sigma strongly desired
- Mastery of software programs - Microsoft Word, PowerPoint, Excel, Project, Minitab
- Effectively influencing and negotiating with all levels of an organization and leading effective/successful change initiatives
7
Senior Design Quality Engineer, Advanced Resume Examples & Samples
- Understand how to take a user need to a quantifiable specification (ex. Force, output, time, etc.)
- Identifies areas for improving intuitive use, usability of products through usability protocols, formative studies - executing studies with actual users (surgeon, nurse, technician, specialists)
- Partners with PCBA manufacturers to give guidance for Design For Manufacturability and Design for Test design optimization
- Candidate does not need to be proficient in all areas but must be proficient in some and be able to demonstrate being a quick learner
- 2+ years’ relevant job or academic experience
- Hands on Electrical hardware engineering experience
- PCBA, FPGA experience highly desired
- Software or programming experience preferred but not required
- Demonstrated pattern of technical innovation, collaboration, and creativity, inside and outside of previous job duties
- BS in Electrical Engineering, Computer Engineering, or a related field
- ASQ CQI, CQE, CRE, or P.E. desired but not required
8
Senior Design Quality Engineer APV Resume Examples & Samples
- Bachelor’s Degree in Engineering or Science (Life Sciences, Physics, ME, EE, Industrial Technology, etc.)
- 2+ years related engineering experience with an M.S. degree
- Extensive knowledge of quality tools
9
Senior Design Quality Engineer Resume Examples & Samples
- 4+ years of experience with a Bachelor’s degree
- Ability to conduct hands-on technical work
- Extensive knowledge and application of quality tools
10
Senior Design Quality Engineer Resume Examples & Samples
- Product development team member focused on product development and life cycle management activities related to the Trauma/CMF business
- Lead design and development planning activities for new and sustaining projects
- Participate in all aspects of the creation and execution of functional/design requirements for new and sustaining projects
- Conduct formal technical design reviews throughout the phases of the product development process
- Support and approve design verification/validation activities including mechanical testing, tolerance analyses, design rationales, and surgeon based anatomical labs
- Apply statistical methods and design excellence tools to design verification and validation activities
- Support risk management activities including planning, design & clinical risk management, production risk management, and overall risk summary reporting
- Lead the cascade of critical to quality design features to product quality plans and downstream manufacturing & quality processes. He/she will support transfer to manufacturing activities both in product development and base businesses
- Enhance the design control and risk management processes to better reflect state of the art practices and drive continuous improvement
- Provide leadership in all areas of the Quality System, including, but not limited to corrective & preventive actions, product complaints, post market surveillance, nonconforming materials, risk management, and audit support functions
- Provide leadership in the understanding of medical device regulations to other disciplines
- Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Product Development, Regulatory, Manufacturing, and Marketing
- A minimum of a Bachelor Degree in Engineering and/or in a Technical Science is required. A Master’s degree is a plus
- A minimum of 4 years related working experience in a GMP and/or ISO regulated industry is required
- Strong design/quality engineering skills with a proven track record in all aspects of the design control process, including functional/design requirements, design verification/validation, and product risk management is required
- Previous experience in a medical device or a healthcare discipline is strongly preferred
- Strong working knowledge of QSR (21 CFR 820) and ISO (13485, 14971) quality requirements is strongly preferred
- Knowledge of process and design excellence tools is strongly preferred
- An ASQ certification (CQE, CQM, CRE or CQA) is preferred. Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is preferred
- Candidate should possess excellent problem solving, decision-making, and root cause analysis skills in addition to interpersonal skills that foster conflict resolution as it relates to technical situations
- Candidate should have a proven track record implementing Quality System improvements to meet compliance and overall business goals. Proficiency with the Microsoft Office Suite is required
- This position will be based in West Chester, PA and will require up to 10% travel, including potential international
11
Senior Design Quality Engineer Resume Examples & Samples
- Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulations
- Assist in the creation of verification and validation test plans, protocols and reports. Oversee testing and analysis for standards and product requirements compliance
- Ensure successful transfer of new products to production facility by assisting in the development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques
- Computer literate and experience with PCs, networks, and applications
- Familiar with DMAIC or DMADV(DFSS) methodologies Desirable
12
Senior Design Quality Engineer Resume Examples & Samples
- Take part in process improvement activities
- Provide technical support and methods to assist production
- Lead and solve any quality issue as required
- Family with test plan and execution of test plan
- Understand quality system requirements
- Good English Skill and Mandarin skills
- Positive attitude & good communication skills
13
Senior Design Quality Engineer Resume Examples & Samples
- Provide technical and statistical reliability support to Product Development, Manufacturing and Quality organizations
- Contribute to New Product Introduction Projects as a core team member and communicate activities to the extended team members of Quality
- Support the product development teams in the adoption and use of best practices, Quality tools, and Design Control methodologies
- Perform Risk Analysis including Fault Tree Analysis (FTA), Human Factors/Usability, and Failure Mode and Effects Analysis (FMEA) activities to ensure risks are identified and appropriately addressed
- Monitor and develop reliability improvements to existing & new designs
- Support Post Market Surveillance in the investigation of product complaints to determine the root cause and recommend appropriate corrective and preventive action to prevent recurrence
- Work with other Groups to maintain an approved internal Quality System that meets the requirements of GMP’s, QSR 21 CFR Part 820 and ISO 13485
- Evaluate quality data and prepare periodic reports to monitor trends
- Generate, review and approve Engineering and Development Change Orders for Design Assurance
14
Senior Design Quality Engineer Resume Examples & Samples
- Minimum of a Bachelor’s Degree in Engineering (HVAC&R product engineering experience preferred) with 5 plus years of experience in APQP, statistics, quality or related field
- Experience in advanced quality, quality systems, problem solving skills (8D, CAPS, KT, etc.), product/project management and strong facilitation skills
- Possess strong oral, written and listening communication skills and strong in team building skills
- Experience in Verification, Validation, and Life Cycle Testing with Six Sigma (DMAIC) tools, Six Sigma Black Belt certification would be preferred, Design for Six Sigma (IDOV) experience would be desired
15
Senior Design Quality Engineer Resume Examples & Samples
- Contribute to New Product Development projects as a core team member and communicate activities to the Regulatory Affairs and Quality extended team members
- Provide effective quality engineering support for new product transitions into commercial production
- Ensure clarity and consistency in acceptance criteria and that verification and validation processes used are capable
- Provide technical and statistical reliability support to Product Development, Manufacturing, and Quality organizations
- Lead major efforts, or phases of projects, to resolve complex technical and Quality-related problems
- Provide effective support for multiple projects, balancing priorities and resources appropriately to meet both project and management expectations
- Responsible for the assessment of technical standards against current DHF, labeling and technical file requirements to characterize gaps
- Perform Risk Analysis and Failure Mode and Effects Analysis (FMEA) activities to ensure risks are identified and appropriately addressed
- Support Risk Management activities to ensure design and process shortcomings are identified and appropriately addressed
- Develop reliability improvements to existing & new designs
- Work with other groups to maintain an approved internal Quality System that meets the requirements of QSR 21 CFR Part 820 and ISO 13485
- Evaluate quality data and prepare periodic reports
- Generate, review, and approve Engineering Change Orders for Design Assurance
- Support corrective and preventive action activities related to product development and design change
- It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem
- Bachelor's Degree in Engineering or other similar Technical Discipline; or 4 years related experience
- 7+ years related Quality Assurance/Quality Engineering/Design Assurance experience
- 4+ years Medical Device Industry
- ASQ Certification(s) a plus, Six Sigma experience highly desirable
- Excellent working knowledge of FDA Quality System Regulation 21 CFR Part 820 and ISO13485 required
- Excellent verbal communication and technical writing skills
16
Senior Design Quality Engineer Resume Examples & Samples
- Support new product development and design through verification and validation activities
- Support maintenance of existing products including but not limited to design changes, process changes, supplier changes, remediation, recertification and brand extensions
- Function as a quality lead on multiple product development teams in matters relating to Quality Engineering
- Ensure effective and efficient use of Quality Engineering techniques such as risk analysis, test method development, statistical data analysis, and the development of sample plans
- Lead and ensure the development of comprehensive risk management plans for the product, that critical design information is translated to the manufacturing site and that effective and comprehensive quality strategies/controls exist for the process
- Communicate at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing
- Provide guidance to project teams, suppliers and other disciplines to ensure compliance with company policies and procedures as well as medical device regulations
- Lead investigation of quality issues and effective corrective and/or preventive action
- Provide people leadership experience as this role may expand to have responsibility for a team of engineers
- A minimum of a Bachelor’s degree in Engineering or related technical or scientific discipline with a minimum of 7+ years of experience in related field is required. A Master’s degree in a technical discipline is an asset
- Excellent problem solving, decision-making, and root cause analysis skills are required
- Interpersonal skills that foster conflict resolution are required
- Experience with Blueprint reading/literacy including GD&T is required
- Working knowledge of Design Controls, GMPs, QSR, 21 CFR 820, MDD 93/42/EEC, ISO13485 and ISO14971 quality
- Previous experience in a medical device or a healthcare discipline is preferred
- Strong quality engineering skills with a proven track record in design verification/validation, process verification/validation, and design/process Failure Mode and Effects Analysis is preferred
- Development and manufacturing experience is preferred
- Knowledge of process and design excellence tools is strongly preferred. Process Excellence certification is a plus
- Fluency in English is required, good knowledge of German would be a strong asset
- Willingness to travel (10%)
17
Senior Design Quality Engineer Resume Examples & Samples
- Experience in the facilitation of effective DMEAs/DFMECAs for complex electromechanical systems
- Knowledge of Standards Applicable to Medical Device Safety/Risk Management (ISO 13485, ISO 14971, ISO 62303, IEC 60601-1, US 21 CFR Part 820, and related standards)
- Experienced in the practical application of Systems Engineering and Systems Verification principles
- Knowledge of Design Control Systems and ability to apply project management techniques
- Experience with supplier management and component qualification practices
- Experience managing a comprehensive risk management process for complex medical devices
- Working knowledge of quality engineering principles, supplier management, and manufacturing operations within a regulated industry (preferably medical devices)
- Proficient with utilization of quality tools (Six Sigma, Statistical Techniques, Sampling Principles, Risk Assessment, Root Cause Analysis, FMEA, FTA, DOE, etc.)
- Experience with Minitab or similar statistical analysis tools
- Experience with Geometric Dimensional and Tolerancing (GD&T)
- Fundamental understanding of electronic and electromechanical designs and manufacturing processes to support designing, troubleshooting, refining and qualifying the design to ensure the sustainable manufacturing of medical devices both internal and external
18
Senior Design Quality Engineer Resume Examples & Samples
- Combination Product experience (development or manufacturing)
- ASQ CQE or CQA
- Familiar with regulations: FDA 21 CFR Part 820, Part 211, Part 4, ISO 13485
19
Senior Design Quality Engineer New Product Development Resume Examples & Samples
- Bachelors Degree (B.S.) in mechanical engineering, mechanical engineering technology, biomedical engineering (or other technical degree applicable to position being filled) or related discipline from an accredited university and a minimum of seven (7) years related experience
- Experience in product development with complex systems (mechanical, electrical, software, chemistry), including systems engineering and software design and development
- Experience developing business processes and quality systems enhancements (product design through manufacturing) in a mature industry that has stringent quality regulations
- Ability to constructively challenge designs and engage in transparent conversations
- Ability to identify, analyze and solve problems with minimal direction and make decisions with confidence
- Superior communication skills, both oral and written and ability to develop cross functional partnerships
- High degree of initiative and self motivation. Strong analytical skills and the ability to solve problems through analytical reasoning
- Proficient with Microsoft Office (Word, Excel, PowerPoint)
- Overnight travel (up to 15%) may be required
20
Senior Design Quality Engineer Resume Examples & Samples
- Provide ongoing quality engineering support throughout the product life cycle. Provide support to development, engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs and requirements
- Drive product risk management activities and ensure quality and completeness of project design history files, validation packages, and change orders
- Identify areas and opportunities to improve quality system processes
- Ensure product development and validation programs meet requirements of FDA and ISO when applicable
- Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
- Take initiative to identify and drive improvements to the Illumina quality system
21
Senior Design Quality Engineer Resume Examples & Samples
- Evaluates product design and identifies potential design quality issues and drive technical decisions
- 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
- Accountable for ensuring Design Verification and Validation execution and deliverables comply with quality system regulations and internal requirements
- Supports design test and inspection method development and validation
- Ensures DHF and DMR content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
- 5-7 years of experience with a Bachelor’s Degree in a technical/engineering discipline; or
- 3-5 years of experience with a Master’s Degree in a technical/engineering discipline; or
22
Senior Design Quality Engineer Resume Examples & Samples
- Bachelor of Science degree in Engineering, Physics, Biology, or similar
- 5 or more years of experience in a medical device company in a Quality or Compliance role, or 10 or more years of experience in a related role in a medical device company
- Skilled in product risk assessment (ISO 14971), requirements management and tracing, defect tracking, and configuration management techniques
- Understanding of current Quality techniques, industry standards (e.g. ISO, IEEE, CMMI), and FDA Quality System Regulations and their impact on internal procedures, quality, safety, and efficacy of products
- Experience with standards for the design, verification, and validation of medical device products
23
Senior Design Quality Engineer Resume Examples & Samples
- Actively represent Quality Assurance function on product/process project teams. - Mentor less senior Quality Engineers and quality technicians, including training, motivating, monitoring, and evaluation
- Provide guidance to Engineering staff and other personnel and ensures 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
- Lead the investigation of complex product problems. Identify and manage corrective actions resulting from problem investigations
- Master’s Degree in Engineering or Science (Life Sciences, Physics, ME, EE, Industrial technology, etc.)
- Experience in the Medical Device Industry
