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
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