Lead Software Design Assurance Engineer

Are you passionate about ensuring the quality safety and reliability of life-saving medical device software Hologic is seeking a Lead Software Design Assurance Engineer to play a critical role in driving compliance innovation and excellence in software development for both Software as a Medical Device (SaMD) and embedded systems (SiMD). In this role youll lead design controls risk management processes and rigorous verification and validation (V&V) strategies ensuring our software meets the highest global regulatory standards. If youre an experienced professional with a strong background in software engineering regulatory compliance and mentoring this is your opportunity to make a meaningful impact on healthcare innovation.

Knowledge:

• 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.

Skills:

• Proven ability to lead design assurance efforts for software in medical devices ensuring compliance and safety throughout the product lifecycle.
• Expertise in defining and executing robust software verification and validation (V&V) strategies including test method validation.
• Skilled in integrating automated testing into CI/CD pipelines and leveraging data analytics for continuous improvement.
• Strong project management skills to oversee design controls manage documentation and evaluate product change requests.
• Proficiency in statistical tools (e.g. Minitab) for data analysis and decision-making.
• Advanced technical communication skills to present findings collaborate cross-functionally and support audits and inspections.
• Mentorship abilities to guide and develop junior engineers fostering a culture of innovation and compliance.

Behaviors:

• 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.
• Continuous improvement mindset constantly refining processes and adopting best practices to enhance efficiency and product performance.
• Strategic thinker with the ability to translate complex technical concepts into actionable plans.

Experience:

• Bachelors degree in Computer Science Software Engineering Electrical Engineering or related discipline required; Masters degree preferred.
• 8 years of experience in medical device software development with a Bachelors degree or 5 years with a Masters degree in Computer Science Software Engineering Electrical Engineering or a related field.
• Hands-on experience with software design assurance activities including V&V risk management and regulatory compliance.
• Demonstrated expertise in software security usability engineering and integrating automated testing into development pipelines.
• Proven track record of supporting regulatory audits and inspections with strong knowledge of Design History File (DHF) and technical documentation requirements.

Why join Hologic

We are committed to making Hologic the destination for top talent. For you to succeed we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

The annualized base salary range for this role is $119300-$186600 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience skillset knowledge education business needs and market demand.

Agency and Third-Party Recruiter Notice

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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