Hologic, Inc. · 2 months ago
Lead Software Design Assurance Engineer
Marlborough, MA, United States
Full-time
Onsite
Senior Level, Lead/Staff
$119K/yr - $187K/yr
8+ years expHologic, Inc. is seeking a Lead Software Design Assurance Engineer to play a critical role in driving compliance, innovation, and excellence in software development for medical devices. The role involves leading design controls and risk management processes to ensure software meets global regulatory standards.
BiotechnologyHealth CareHealth DiagnosticsWomen's
Responsibilities
Lead design controls, risk management processes, and rigorous verification and validation (V&V) strategies
Ensure software meets the highest global regulatory standards
Define and execute robust software verification and validation (V&V) strategies, including test method validation
Integrate automated testing into CI/CD pipelines and leverage data analytics for continuous improvement
Oversee design controls, manage documentation, and evaluate product change requests
Present findings, collaborate cross-functionally, and support audits and inspections
Guide and develop junior engineers, fostering a culture of innovation and compliance
Qualification
Required
Bachelor's degree in Computer Science, Software Engineering, Electrical Engineering, or related discipline required
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
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
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
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
Preferred
Master's degree preferred
Benefits
Comprehensive training when you join as well as continued development and training throughout your career
Bonus eligible
Company
Hologic, Inc.
We’re an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day.
5001-10000 employees
H1B Sponsorship
Hologic, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (31)
2024 (20)
2023 (15)
2022 (32)
2021 (20)
2020 (14)
Funding
Current Stage
Public CompanyTotal Funding
$2.87B2025-10-21Private Equity
2025-10-21Acquired
2025-07-15Post Ipo Debt· $2.42B
Leadership Team
Stephen MacMillan
Chairman President & CEO
Karen Harrington
Director Scientific Affairs
Recent News
2026-01-08
Company data provided by crunchbase