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Design Quality Engineer, Medical Devices & Imaging

Job in Roswell, Fulton County, Georgia, 30076, USA
Listing for: Apptad Inc
Full Time position
Listed on 2026-06-30
Job specializations:
  • Engineering
    Quality Engineering, Medical Device Industry
Job Description & How to Apply Below

Design Quality Engineer (526951) MULTIPLE OPENINGS USA (Bothell, WA | Cambridge, MA | Plymouth, MN or Reedsville, PA)

Job 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
Ability to:
  • Identify design gaps early
  • Drive risk-based decisions
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