Design Quality engineer

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.

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