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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:
- Review Customer, Product and Subsystem requirements to ensure consistency, coverage, traceability and testability.
- Conduct impact analysis and evaluate which compliance evidences need to be reassessed or provided during design change.
- Define Verification and Validation strategy that ensures full requirement coverage, defect detectability, optimize time and resources.
- Write verification and validation protocols
- Compile data and write test reports.
- Drive V&V activities and functionally lead testing team including engineers and technicians.
- Responsible for establishing testing planning and ensuring availability of resources, tools and test samples.
- Develop automation of tests with a risk-based approach to accelerate testing, optimize coverage and repeatability.
- Identify strengths and weaknesses, and propose short term quick wins and long-term improvement plans with formalized business cases.
- 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.
- Organize and lead formative usability testing for NPI projects.
- Responsible for usability and human factors engineering files.
- Create and use performance indicators to drive product quality during the development phase.
- Organize and develop exploratory, integration and reliability testing.
- Update Procedures to reflect improvements in QMS.
Knowledge, Skills and Abilities Required
- MS with 5+ years of experience, or BS and 7+ years of experience in relevant technical disciplines
- At least 3 years of experience in the development of medical devices or other highly regulated industry.
- Experience in driving Design Verification and Validation activities.
- Ability to design and setup automated test benches.
- Experience with automated test bench GAMP5 validation.
- Experience with automated test bench programming (i.e. Python, Labview)
- Strong knowledge of sample size determination principles.
- Familiarity with a statistical software tool is a plus (i.e. Minitab).
- Knowledge of six sigma and value stream mapping techniques.
- Familiarity with stress testing, including accelerated ageing and transit testing.
- Excellent understanding of design control processes as defined per ISO13485 and FDA 21 CFR Part 820.
- Knowledge of usability standard applied to medical devices IEC 62366.
- Familiarity with risk management ISO 14971.
- Good interpersonal skills with demonstrated ability to work in an international environment.
- Familiarity with requirements and changes management systems (i.e. Rational Doors and Change)
- Proficient use with Microsoft Office products Word, Excel, and Power Point
- Experience in project management and the use of Microsoft Project a plus.
- Excellent written and verbal communication skills.
Reporting Relationships
Reports to: D&E Software Manager