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Senior Design Quality Engineer, Medical Devices; Regulatory

Job in Newton, Middlesex County, Massachusetts, 02165, USA
Listing for: CONFLUX SYSTEMS
Full Time position
Listed on 2026-03-01
Job specializations:
  • Engineering
    Quality Engineering, Biomedical Engineer, Medical Device Industry, Systems Engineer
Salary/Wage Range or Industry Benchmark: 80000 - 100000 USD Yearly USD 80000.00 100000.00 YEAR
Job Description & How to Apply Below
Position: Senior Design Quality Engineer, Medical Devices (Regulatory)
A leading medical systems company is seeking an experienced Senior Design Quality Engineer to support the development of complex robotic and electromechanical Class III medical systems. The role includes ensuring compliance with FDA and ISO standards, leading risk management efforts, and maintaining design traceability. Candidates should have a Bachelor's degree in Engineering and 7-10 years of experience in design quality within the medical device sector, with strong skills in design controls and risk assessments.
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Position Requirements
10+ Years work experience
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