Senior Systems Verification and Validation (V&V) Engineer

Roles & Responsibilities

• Learn from and adhere to internal quality manual (Quality System Procedures, Work Instructions, Forms).
• Interact with cross-functional project teams to provide inputs to project plans and schedules.
• Estimate resource needs for project support.
• Review requirements and scrutinize for testability.
• Develop V&V test plans, test procedures, requirements trace matrices, and test reports.
• Assign project tasks and responsibilities to V&V team.
• Act as advisor to team to meet schedules and solve technical problems.
• Quickly learn to use automated test tools and specialty test equipment; develop and validate Client test methods (TMV, DOE, Gage R&R studies).
• Execute test procedures both personally and using test technicians.
• Log defects and issues found during V&V activities and track to closure.
• Participate in defect review boards.
• Perform regression analysis and determine testing associated with design changes.
• Plan and facilitate V&V formal technical review and design review meetings.
• Provide weekly project status reports.
• Prioritize project tasks to complete on schedule while maintaining quality of work.
• Work in a team environment; peer review work.
• Work on multiple, concurrent projects.

Must Have Qualifications

• Bachelor's degree in an engineering discipline; electrical engineering or mechanical engineer background preferred.
• 5 years professional experience in the medical device industry.
• Working knowledge of global medical device regulations, requirements, and standards.
• Experience developing V&V test plans, test procedures, requirements trace matrices, and test reports.
• Experience validating test methods (TMV) using methods such as DOE and Gage R&R.
• Experience with ventilators, sleep therapy devices, oxygen concentrators, personal wellness devices, and associated accessories.
• Experience with specialized test equipment such as TSI Flow Analyzer, Meriam Pressure Analyzer, IMT Analytics Vent Analyzer, Oxigraf Oxygen Analyzer, VI Acoustics Hardware/Software, Cincinnati Sub Zero Environmental Chamber, Thermotron Environmental Chamber, Ingmar Automated Servo Lung.