Hologic is seeking a Lead Software Design Assurance Engineer to ensure the quality, safety, and reliability of life-saving medical device software, driving compliance, innovation, and excellence in software development for both Software as a Medical Device (SaMD) and embedded systems (SiMD).
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.
- Demonstrated expertise in software security, usability engineering, and integrating automated testing into development pipelines.
Responsibilities
- lead design controls, risk management processes, and rigorous verification and validation (V&V) strategies, ensuring our software meets the highest global regulatory standards.
- lead design assurance efforts for software in medical devices, ensuring compliance and safety throughout the product lifecycle.
- defining and executing robust software verification and validation (V&V) strategies, including test method validation.
- integrating automated testing into CI/CD pipelines and leveraging data analytics for continuous improvement.
- project management skills to oversee design controls, manage documentation, and evaluate product change requests.
- statistical tools (e.g., Minitab) for data analysis and decision-making.
- supporting audits and inspections.
Other
- Mentorship abilities to guide and develop junior engineers, fostering a culture of innovation and compliance.
- Ownership-driven, taking responsibility for the integrity of software design controls and ensuring timely execution of deliverables.
- Detail-oriented and proactive, ensuring that compliance, safety, and quality are embedded in every phase of software development.
- Collaborative and team-oriented, building strong cross-functional partnerships to drive innovation and achieve shared goals.
- Problem-solving mindset, creatively addressing software challenges without compromising quality or compliance.
