Design Assurance Engineer 3
HologicNewark, Delaware, United States • Marlborough, Massachusetts, United States
Posted March 20, 2026
Full Time
About the Company
Hologic is an innovative medical technology company dedicated to enabling healthier lives through groundbreaking products and services. Specializing in Breast & Skeletal Health, Diagnostic Solutions, and GYN Surgical Solutions, the company excels in early detection and treatment of health conditions, driven by a commitment to women's health and a focus on clinical superiority. Hologic fosters a culture of expertise, dedication, and continuous improvement to meet unmet health needs globally.
Job Description
Design Assurance Engineer 3 will embed quality, compliance, and safety into medical devices throughout their life cycle. They will leverage technical expertise and collaborative skills to drive product excellence and regulatory compliance.
Requirements
- Comprehensive understanding of design control, risk management, quality systems, and change management for regulated medical devices
- Deep familiarity with FDA Medical Devices 820 Quality System Regulation, ISO 13485, ISO 14971:2019, EU Medical Device Directive (MDD), and Medical Device Regulation (MDR)
- Working knowledge of Good Laboratory Practices, Usability, Reliability, Electrical Safety, and Software standards/regulations
- Expertise in requirements analysis, including development of testable and measurable specifications, as well as verification and validation for regulated products
- Integrated knowledge of product performance accuracy and clinical efficacy, supporting quality and compliance throughout the device life cycle
Benefits
- Annualized base salary range: $97,600-$152,700
- Bonus eligible
- Comprehensive training and continued development and training throughout career
- Equal Opportunity Employer inclusive of disability and veterans