Job Title
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.
Skill Requirement
Strong understanding of: Design controls & product lifecycle Systems engineering
Experience In
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