A stable startup company in the north developing an innovative medical system needs a Verification Validation Leading Engineer (Console Disposable) part of our design/improvement team.
Role Purpose:
Own hands-on execution of verification and validation activities for a combined console and disposable medical device system, ensuring timely, compliant, and traceable evidence to support FDA Pre-Submission and subsequent regulatory submissions. Supporting the Development and Clinical department tasks.
Key Responsibilities:
- Execute verification and validation testing for console hardware, software (black-box/ system level), and disposable components
- Author verification and validation protocols based on approved system and design requirements
- Develop, qualify, and maintain TEST methods, fixtures, and setups
- Execute tests, ensure data integrity, and generate clear, reviewable TEST
Requirements: - Degree in relevant engineering fields.
- Team member, leading/taking responsibilities
- 5+ years hands-on V V or system TEST experience in medical devices or regulated products
- Experience with design controls, TEST protocols, and reports
- Comfortable in startup environments with limited infrastructure
- Experience testing multi-disciplinary systems (HW + SW + disposables)
This position is open to all candidates.