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Senior Design Assurance Engineer - Medical Devices

Job in Billerica, Middlesex County, Massachusetts, 01821, USA
Listing for: Pivotal Solutions
Full Time position
Listed on 2026-06-26
Job specializations:
  • Engineering
    Quality Engineering, Medical Device Industry, Biomedical Engineer
Salary/Wage Range or Industry Benchmark: 85000 - 110000 USD Yearly USD 85000.00 110000.00 YEAR
Job Description & How to Apply Below

Pivotal Solutions is recruiting a Senior Design Assurance Quality Engineer in Billerica, Massachusetts. This key contributor manages the Design Control and Risk Management processes for sterile catheters and other medical devices, ensuring compliance with QMS and FDA QMSR requirements.

The ideal candidate will possess a BS degree in Engineering and 5-8 years of experience in design assurance, specifically within a medical device manufacturing environment. This role involves leading cross-functional teams and driving quality-focused design and development to optimize product quality and compliance.

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Position Requirements
10+ Years work experience
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