Design Quality engineer

Katalyst CRO

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 #J-18808-Ljbffr Katalyst CRO

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Vacancy posted 6 days ago

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