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Medical Device Design Quality Engineer - Risk & V&V

Katalyst CRO

Katalyst CRO in Minnesota seeks a Regulatory/Design Controls Engineer to ensure compliance across the medical device lifecycle, with emphasis on ultrasound/imaging domains. You will drive design controls, risk analysis, V&V efforts, and regulatory alignment to ISO 13485 and 14971 while collaborating with cross-functional teams. Ideal candidates have strong systems thinking, experience with DFMEA, and proficiency in requirement management tools, such as DOORS or Jama, to support risk-based #J-18808-Ljbffr Katalyst CRO

Vacancy posted 1 day ago
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