System Validation Engineer

3 weeks ago


Chula Vista, United States Katalyst Healthcares and Life Sciences Full time
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


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