Design Quality Engineer
Apolis
Design Quality EngineerResponsible 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 lifecycleSystems engineeringExperience in:DFMEA / risk analysisRequirement management tools (DOORS, Jama, etc.)V&V execution and reviewRegulatory & Standards KnowledgeMandatory:ISO 13485ISO 14971Preferred:IEC 60601 (electrical safety)IEC 62304 (software lifecycle)IEC 62366 (usability)Ultrasound / Imaging Domain (Preferred)Strong systems thinkingAbility to:Identify design gaps earlyDrive risk-based decisions
Vacancy posted 2 days ago
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