Job Description:
Responsible for ensuring compliance to design controls, risk management, and verification/validation activities across the product lifecycle for medical devices, with a strong preference for ultrasound/imaging systems.
Requirement:- Strong understanding of: Design controls & product lifecycle.
- Systems engineering.
- DFMEA / risk analysis.
- Requirement management tools (DOORS, Jama, etc.).
- V&V execution and review.
- Regulatory & Standards Knowledge
Mandatory:
ISO 13485
ISO 14971
Preferred:
IEC 60601 (electrical safety)
IEC 62304 (software lifecycle)
IEC 62366 (usability)
Ultrasound / Imaging Domain (Preferred)
Strong systems thinking Ability to:
Identify design gaps early
Drive risk-based decisions