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FDA- Design Assurance Engineer

Job in Bellevue, King County, Washington, 98004, USA
Listing for: Hobson Associates
Full Time position
Listed on 2026-10-01
Job specializations:
  • Engineering
    Regulatory Compliance Specialist, Quality Engineering
Job Description & How to Apply Below
Position: FDA-Ready Design Assurance Engineer

Hobson Associates seeks a Design Assurance / Quality Assurance Engineer to be the quality and regulatory standards expert within our R&D organization. Embedded with product teams, you will guide hardware, firmware, and software through the lifecycle—from concept through design transfer, FDA submission, and post-market surveillance—with an emphasis on DHF readiness for 510(k) submission.

The ideal candidate possesses deep knowledge of ISO 14971, IEC 62304, IEC 62366, and IEC 60601 and can apply

As a FDA-Ready Design Assurance Engineer, you will play an important part at Hobson Associates in Bellevue, WA, United States.

Full responsibilities and requirements are described in the listing above.

Learn more about the FDA-Ready Design Assurance Engineer role in the description above.

We appreciate your interest in this position.

Join Hobson Associates and contribute to our ongoing work.

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