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Design Quality Engineer

Apolis

  • Job Title: 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
Vacancy posted 10 hours ago
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