Lead Design Assurance Engineer
HologicNewark, Delaware, United States • Marlborough, Massachusetts, United States
Posted October 30, 2025
119300 - 186600 USD year
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
Hologic is seeking a Lead Design Assurance Engineer to drive innovation and quality in medical device development. The role involves cross-functional collaboration, ensuring regulatory compliance, and improving design assurance processes. This position focuses on defining design requirements, overseeing verification and validation, and championing continuous improvement initiatives.
Requirements
- Deep understanding of medical device regulations and standards (ISO 13485, ISO 14971, IEC 62366, IEC 60601, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, and MDSAP).
- Familiarity with reliability modeling and testing for electro-mechanical devices.
- Expertise in design inputs/requirements analysis, design verification/validation, and design transfer processes.
- Advanced knowledge of risk management principles, including hazard analysis and FMEA.
Benefits
- Comprehensive training
- Continued development