Design Quality engineer
Katalyst HealthCares & Life Sciences
Job TitleResponsible 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 RequirementStrong understanding of: Design controls & product lifecycle Systems engineeringExperience InDFMEA / risk analysis Requirement management tools (DOORS, Jama, etc.) V&V execution and review Regulatory & Standards KnowledgeMandatoryISO 13485 ISO 14971PreferredIEC 60601 (electrical safety) IEC 62304 (software lifecycle) IEC 62366 (usability) Ultrasound / Imaging Domain (Preferred)Strong Systems Thinking Ability ToIdentify design gaps early Drive risk-based decisions
Vacancy posted 2 days ago
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