System Validation Engineer - Katalyst Healthcares & Life Sciences

Responsibilities :

• Interact with cross-functional project teams to provide inputs to project plans and schedules.
• Develop V&V test plans, test procedures, requirements trace matrices, and test reports.
• Assign project tasks and responsibilities to V&V team.
• Quickly learn to use automated test tools and specialty test equipment; develop and validate Client test methods (TMV, DOE, Gage R&R studies).
• Log defects and issues found during V&V activities and track to closure.
• Plan and facilitate V&V formal technical review and design review meetings.

Requirements:

• 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