Design Quality Engineer
Apolis
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
Vacancy posted 1 day ago
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