Design Quality Engineer
Katalyst Healthcares & Life SciencesCambridge, MA
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Overview
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On-site
Job Description
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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FAQs About Design Quality Engineer Jobs at Katalyst Healthcares & Life Sciences
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This job at Katalyst Healthcares & Life Sciences is located in Cambridge, MA, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
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