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Design Quality Engineer
Apolis
🇺🇸 United States
Hybrid
4 months ago
$1 / hour
- Risk Management
- IEC
4 months ago
Not enough detail in this posting to match
- 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
- 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.
- Strong understanding of:
- Design controls & product lifecycle
- Systems engineering
- DFMEA / risk analysis
- Requirement management tools (DOORS, Jama, etc.)
- V&V execution and review
- Regulatory & Standards Knowledge
- ISO 13485
- ISO 14971
Preferred:
- IEC 60601 (electrical safety)
- IEC 62304 (software lifecycle)
- IEC 62366 (usability)
- Ultrasound / Imaging Domain (Preferred)
- Strong systems thinking
- Identify design gaps early
- Drive risk-based decisions
Design Quality Engineer · Apolis