Principal Design Assurance Engineer

Hologic is seeking a Principal Design Assurance Engineer to lead strategic and technical leadership in design controls, risk management, and quality systems for life-changing medical devices. The role involves embedding quality and compliance principles into every stage of development and post-market activities, requiring collaboration with R&D, Regulatory Affairs, and Manufacturing Engineering teams. This position will drive continuous improvement and mentorship of engineers to ensure Hologic’s products meet the highest global standards.

Requirements

• Deep expertise in FDA 21 CFR Part 820 Quality System Regulation, ISO 13485, ISO 14971:2019 (Risk Management), and EU MDR (Regulation 2017/745).
• Advanced understanding of medical device standards, including usability, reliability, electrical safety, and software regulations.
• Thorough knowledge of design control processes, verification and validation planning, and requirements traceability.
• Proficiency in statistical methods, test method validation (TMV), root cause analysis (RCA), and design of experiments (DOE).
• Strong technical writing and communication skills for preparing and presenting complex regulatory and quality concepts.
• Experience with statistical tools like Minitab or JMP and requirements/risk management systems such as Agile, Windchill, or ETQ.

Benefits

• Comprehensive training
• Ongoing development
• Continued career growth