Job DescriptionResponsible 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 RequirementsStrong understanding of: Design controls & product lifecycleSystems engineeringExperience InDFMEA / risk analysisRequirement management tools (DOORS, Jama, etc.)V&V execution and reviewRegulatory & Standards KnowledgeMandatoryISO 13485ISO 14971PreferredIEC 60601 (electrical safety)IEC 62304 (software lifecycle)IEC 62366 (usability)Ultrasound / Imaging Domain (Preferred)Strong systems thinking Ability to:Identify design gaps earlyDrive risk-based decisions#J-18808-Ljbffr
| Location | Minneapolis, MN |