Design Quality Engineer – Medical Device (Medical Devices / Healthcare Technology / Imaging Systems) Certitude Business Solutions (CBSLLC) in United States

Now hiring: Design Quality Engineer – Medical Device at Certitude Business Solutions (CBSLLC) for onsite roles in Bothell, WA, Cambridge, MA, Plymouth, MN, or Reedsville, PA.

This is a job opening in medical devices / healthcare technology / imaging systems, with a strong focus on medical device quality, design controls, risk management, systems engineering, verification and validation, and DFMEA. The role involves supporting compliance across the product lifecycle, collaborating with cross-functional engineering teams, identifying design gaps early, and contributing to ultrasound and imaging system development.

Required experience includes ISO 13485 and ISO 14971. Preferred expertise includes IEC 60601 (electrical safety), IEC 62304 (software lifecycle), IEC 62366 (usability engineering), and experience with ultrasound/imaging systems. Familiarity with requirement management tools such as DOORS or Jama is also highlighted.

To apply, send your updated resume to [email protected]. For immediate consideration, contact 908-671-4095. No deadline or funding details are provided.