Design Quality engineer

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