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Medical Device Industry Biomedical Engineer Quality Engineering Regulatory Compliance Specialist

Senior Medical Device Compliance Lead: Design Controls

Job in Needham, Norfolk County, Massachusetts, 02492, USA
Listing for: SharkNinja
Full Time position
Listed on 2026-05-19
Job specializations:
  • Engineering
    Medical Device Industry, Biomedical Engineer, Quality Engineering, Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 130500 - 159500 USD Yearly USD 130500.00 159500.00 YEAR
Job Description & How to Apply Below
Shark Ninja is looking for a Senior Medical Device Compliance Engineer to oversee medical device design control and post-market compliance. The role collaborates closely with various teams and involves creating Design History Files, ensuring regulatory compliance, and supporting audits. Candidates should possess a Bachelor’s or Master’s degree in Engineering, have 5+ years of relevant experience, and strong expertise in risk management and design controls.

The annual salary ranges from $130,500 to $159,500 with comprehensive benefits.
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Position Requirements
10+ Years work experience
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