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Design Quality Engineer Location:
(Bothell, WA | Cambridge, MA |Plymouth, MN or Reedsville, PA) ONSITE Tax Term (W2, C2C): Both Job Type (Permanent/Contract) : Contract Duration: 6+ months Pay Range: $47 - $50/hr on W2 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 bility to:
Identify design gaps early Drive risk-based decisions
Sprachkenntnisse
- English
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