Lead Software Design Assurance Engineer
HologicMarlborough, Massachusetts, United States • Newark, New Jersey, 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 Software Design Assurance Engineer to ensure the quality, safety, and reliability of life-saving medical device software. The role involves driving compliance, innovation, and excellence in software development, including design controls, risk management, and verification and validation. This position requires a strong background in software engineering, regulatory compliance, and mentoring.
Requirements
- Deep understanding of global medical device software regulations, including FDA 21 CFR Part 820, EU MDR, ISO 13485, and IEC 62304.
- Expertise in Software Development Life Cycle (SDLC) for safety-critical applications, including Agile/iterative design controls.
- Advanced knowledge of risk management frameworks (ISO 14971), including hazard analysis and FMEA.
- Familiarity with usability engineering (IEC 62366) and its application to enhance product safety and effectiveness.
- Awareness of software security principles, including threat modeling, vulnerability assessments, and penetration testing.
- Knowledge of AI/ML regulatory and safety challenges in medical devices.
Benefits
- Comprehensive training
- Continuing development and training
- Ongoing support
- Opportunity for growth
