Lead Compliance Engineer, R&D

Hologic is a global leader in medical device innovation, dedicated to improving lives through advanced technology and rigorous quality standards. As we expand our portfolio and reach, we are looking for a talented Lead Compliance Engineer to join our Research & Development (R&D) team and drive product compliance for our global markets. As the Lead Compliance Engineer, R&D , you will define and execute product compliance strategies, policies, and processes to ensure Hologic’s medical products meet regulatory standards and achieve necessary certifications such as ISO, FCC, UL, IEEE. You will serve as the technical subject matter expert, working closely with regulatory agencies, participating in product design reviews, and guiding cross‑functional teams to prevent compliance issues from initial design through production and delivery. You will oversee both internal and external compliance testing, maintain documentation, and ensure supplier adherence to domestic and international requirements. With your wide-ranging experience, you will resolve complex issues, determine new methods and procedures, and may coordinate activities of other personnel as a team lead. Key Responsibilities Develop and implement compliance strategies for global regulatory standards (EU MDR, EMC/EMI, safety compliance, etc.) throughout the product lifecycle. Serve as the primary technical expert for regulatory compliance, supporting Program Management, Regulatory Assurance, and R&D teams. Participate in product technical reviews and testing to identify areas of risk for compliance, troubleshoot compliance issues, and provide recommendations to improve designs. Conduct product design reviews, identify applicable regulatory standards, and provide compliance training to prevent issues. Oversee EMC, environmental, and IEC 60601‑1 compliance testing at certified labs; act as liaison with agencies such as UL, CSA, TUV, BSI. Drive compliance activities for new product launches, post‑launch changes, and corrective actions to ensure ongoing regulatory compliance. Support internal and third‑party audits and prepare and review documentation for test labs and regulatory bodies. Create compliance program plans, certification test plans, verification procedures, and reports. Collaborate with engineering, marketing, systems, and manufacturing teams to implement compliance requirements into product definitions. Manage multiple projects and priorities, contributing to NPD, CAPA, cost reduction, EOL, and operations support projects. Mentor and train junior engineers as needed. Physical Demands Sit, stand, walk, reach, stoop, kneel, crouch, crawl. Lift/move/carry products up to 40 pounds. Exposure to moving mechanical parts, vibration, and moderate noise. Qualifications Bachelor’s degree required; Master’s or PhD in a technical field strongly preferred. 8+ years of experience (or 6+ years with a Master’s, 3+ years with a PhD) in compliance testing for product devices and international certifications. Experience with wireless technologies (Wi‑Fi, RFID) and electrical test equipment (spectrum analyzers, vector network analyzers, signal generators). Strong understanding of medical device compliance and safety standards, device manufacturing, and product lifecycle processes. Ability to troubleshoot and resolve complex EMC issues. Experience leading cross‑functional teams and projects. Logical thinking, mature engineering judgement, and strong analytical/problem‑solving skills. Effective collaboration and communication skills with technical and non‑technical colleagues. Proficiency in revision control and at least one software language (e.g., Python). Familiarity with FDA, FAA, DoD, ISO environments and risk assessment management. Proficient in Microsoft Office Suite (Excel, Word, PowerPoint). Ability to mentor and train junior engineers is a plus. Why Join Hologic? We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we provide comprehensive training when you join and continued development throughout your career. We offer a competitive salary and annual bonus scheme, and our talent partners can discuss details with you. Compensation The annualized base salary range for this role is $111,400 – $174,300 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand. Equal Opportunity Employer Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. Location Newark, DE, United States #J-18808-Ljbffr Hologic, Inc.