Lead Software Design Assurance Engineer Newark, DE, United States Marlborough, MA, United States **Lead Software Design Assurance Engineer** **Summary:** In this role, you will leverage your expertise in design control, risk management, software development, and quality systems to ensure our medical devices, particularly those involving Software as a Medical Device (SaMD), are safe, effective, and compliant with regulatory standards. **Essential Duties and Responsibilities:** + Apply extensive knowledge of **Software as a Medical Device (SaMD)** , including its design, development, usability, compliance, and risk management. + Leverage expertise in **AI software** applications within medical devices to ensure compliance with regulatory standards and safety requirements. + Leads the planning and execution of design assurance activities, including risk management, verification, and validation. + Serve as a technical mentor to junior engineers, providing guidance on complex technical challenges, + Thorough understanding of system and software design controls, participates in cross functional team meetings, software bug triage meetings to discuss, investigate and appropriately disposition internal software bugs and software field issues. + Participate in Cybersecurity related discussions and assist supporting activities + Assist in the design and development of software test cases and inspection procedures. + Understanding of Software Development Life Cycle (SDLC) + Ensure safety and effectiveness are integral to the design and maintenance of medical devices through rigorous design control, risk management, quality systems, and change management practices. + Support **software design control** , including usability, risk management, and software compliance throughout the product lifecycle. + Lead remediation activities for one specific product, addressing gaps and ensuring compliance with regulatory requirements. + Implement and maintain risk management processes throughout the device lifecycle, with a focus on software risk management. + Support validation, verification, and clinical preparation activities as required during product development or transfers. + Analyze and resolve complex issues creatively and effectively, ensuring innovative solutions align with quality and compliance standards. **Qualifications:** + Deep technical knowledge of **SaMD** , including regulatory requirements such as FDA 21 CFR Part 820 (Design Control), ISO 13485, ISO 14971, and IEC 62304. + Strong understanding of **software risk management** , usability engineering, and compliance processes. + Experience with **AI software** integration into medical devices, including validation and verification. + Working knowledge of test method validation, root cause failure analysis, statistical methods, and design of experiments. + Ability to effectively collaborate on project teams, take leadership roles, and drive action in accordance with Deming Cycle (PDCA) principles. + Strong written and verbal communication skills, with the ability to assess and communicate compliance requirements effectively. **Education:** + Bachelor’s Degree in Computer Science, Software Engineering or a related field (Master’s or PhD preferred). **Experience:** + 8 years of experience in medical devices with at least 6years of experience in **software development for medical devices** or other highly regulated industries. + Hands-on experience in **design control for software in medical devices** , including risk management and usability + Proven expertise in **quality systems** and compliance for regulated products, with a focus on software-related standards and regulations. + Experience in conducting and participating in code reviews is preferred. **Preferred Certifications:** + ASQ Certified Quality Engineer (CQE) + Six Sigma Certification + Familiarity with standards such as IEC 62366 (Usability Engineering), IEC 60601 (Electrical Safety), and IEC 82304 (Health Software). **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 $114,800 to $179,500 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, 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._** \#LI-LL1