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Senior Design Assurance Engineer – Medical Devices

Job in Newton, Middlesex County, Massachusetts, 02165, USA
Listing for: Hologic, Inc.
Full Time position
Listed on 2026-09-08
Job specializations:
  • Business
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 98000 - 153000 USD Yearly USD 98000.00 153000.00 YEAR
Job Description & How to Apply Below

Hologic, Inc. is seeking a seasoned quality/regulatory professional to drive risk management, design controls, and product safety across the lifecycle in a fast‑paced environment in Massachusetts.

You will apply judgment to select methods and techniques and resolve issues creatively with limited day‑to‑day instruction. This role emphasizes PDCA, verification/validation, and regulatory standards (FDA 820, ISO 13485, ISO 14971, EU MDR).

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Position Requirements
10+ Years work experience
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