V&V Architect

The V&V architect is responsible for planning and organizing verification and validation campaigns, and leading usability engineering processes. He/She is also in charge of defining verification and validation strategy as well as continuously improve V&V methods and tools in order to optimize testing activities and improve testing coverage.

Principal Duties and Responsibilities:

1. Review Customer, Product and Subsystem requirements to ensure consistency, coverage, traceability and testability.
2. Conduct impact analysis and evaluate which compliance evidences need to be reassessed or provided during design change.
3. Define Verification and Validation strategy that ensures full requirement coverage, defect detectability, optimize time and resources.
4. Write verification and validation protocols
5. Compile data and write test reports.
6. Drive V&V activities and functionally lead testing team including engineers and technicians.
7. Responsible for establishing testing planning and ensuring availability of resources, tools and test samples.
8. Develop automation of tests with a risk-based approach to accelerate testing, optimize coverage and repeatability.
9. Identify strengths and weaknesses, and propose short term quick wins and long-term improvement plans with formalized business cases.
10. Lead validation and summative usability testing: define strategy & protocols, enroll end users in the testing sessions, conduct testing with end users, collect and formalize relevant feedback.
11. Organize and lead formative usability testing for NPI projects.
12. Responsible for usability and human factors engineering files.
13. Create and use performance indicators to drive product quality during the development phase.
14. Organize and develop exploratory, integration and reliability testing.
15. Update Procedures to reflect improvements in QMS.

Knowledge, Skills and Abilities Required

1. MS with 5+ years of experience, or BS and 7+ years of experience in relevant technical disciplines
2. At least 3 years of experience in the development of medical devices or other highly regulated industry.
3. Experience in driving Design Verification and Validation activities.
4. Ability to design and setup automated test benches.
5. Experience with automated test bench GAMP5 validation.
6. Experience with automated test bench programming (i.e. Python, Labview)
7. Strong knowledge of sample size determination principles.
8. Familiarity with a statistical software tool is a plus (i.e. Minitab).
9. Knowledge of six sigma and value stream mapping techniques.
10. Familiarity with stress testing, including accelerated ageing and transit testing.
11. Excellent understanding of design control processes as defined per ISO13485 and FDA 21 CFR Part 820.
12. Knowledge of usability standard applied to medical devices IEC 62366.
13. Familiarity with risk management ISO 14971.
14. Good interpersonal skills with demonstrated ability to work in an international environment.
15. Familiarity with requirements and changes management systems (i.e. Rational Doors and Change)
16. Proficient use with Microsoft Office products Word, Excel, and Power Point
17. Experience in project management and the use of Microsoft Project a plus.
18. Excellent written and verbal communication skills.
     

Reporting Relationships

Reports to:     D&E Software Manager