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 ensure design controls, risk management, and regulatory compliance during the full lifecycle of new medical device development. This role involves cross-functional collaboration, verification and validation, and continuous improvement to deliver safe and reliable devices. Candidates should possess a strong understanding of medical device regulations and a commitment to innovation.
Requirements
- In-depth 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 and failure investigations.
- Experience with test method validation, statistical analysis, and root cause analysis.
Benefits
- Comprehensive training
- Continued development
- Ongoing development
- Financial incentives
- Opportunities for growth