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Lead Software Design Assurance Engineer

Marlborough, MA, United States

Newark, DE, United States

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, you’ll lead design controls, risk management processes, and rigorous verification and validation (V&V) strategies, ensuring our software meets the highest global regulatory standards. If you’re 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:

+ Bachelor’s degree in Computer Science, Software Engineering, Electrical Engineering, or related discipline required; Master’s degree preferred.

+ 8+ years of experience in medical device software development with a Bachelor’s degree, or 5+ years with a Master’s 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 $119,300-$186,600 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 Department. In 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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