Lead Compliance Engineer, R&D

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Lead Compliance Engineer, R&D

Newark, DE, United States

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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 (e.g., ISO, FCC, UL, IEEE). Serving as the technical subject matter expert, you will work closely with regulatory agencies, participate in product design reviews, and guide 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'll 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.
• As a subject matter expert, participates in product technical reviews and testing to identify areas of risk for compliance, troubleshooting compliance issues, and providing recommendations to improve designs for compliance considerations.
• Participate in product design reviews, identify applicable regulatory standards, and provide training to prevent compliance 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, 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 Master's, 3+ years with 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.
• Proficient in EMC design concepts, lab test equipment (multi-meters, oscilloscopes, spectrum analyzers, etc.).
• 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.

So why join Hologic?

We are committed to making Hologic the company where top talent comes to grow. 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. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.

If you have the right skills and experience and want to join our team, apply today. We can't wait to hear from you!

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.

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.

As part of our commitment to a fair and accurate evaluation of each candidate's qualifications, we require all applicants to refrain from using AI tools, such as generative AI or automated writing assistance, during any stage of the interview process. Responses influenced by AI may result in disqualification. We appreciate your understanding and cooperation in ensuring a transparent and equitable selection process.

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

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