Lead Compliance Engineer, R&D
Not Disclosed•Full-TimeOn-site
location_on224, Ridge Way, Glasgow Pines, New Castle County, Delaware, 19702, United States
About the Team
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, our Research & Development (R&D) team is looking for a talented Lead Compliance Engineer to drive product compliance for our global markets.
About the Role
As the Lead Compliance Engineer, R&D, you will serve as the technical subject matter expert, defining and executing product compliance strategies, policies, and processes. Your mission is to ensure Hologic’s medical products meet regulatory standards and achieve necessary certifications (e.g., ISO, FCC, UL, IEEE). 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.
In this role, 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 coordinate activities as a team lead.
Why Join Hologic?
We are committed to making Hologic the company where top talent comes to grow. To enable your success, we provide comprehensive training upon joining, as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, with details discussed by our talent partners.
Hiring Process & Application
If you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from you!
Important Notice: 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.
Equal Opportunity
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
Work location
Work model: On-site
224, Ridge Way, Glasgow Pines, New Castle County, Delaware, 19702, United States
Delaware
Key Responsibilities
- check_circleDevelop and implement compliance strategies for global regulatory standards throughout the product lifecycle
- check_circleServe as the primary technical expert for regulatory compliance supporting R&D and Program Management teams
- check_circleParticipate in product design reviews to identify applicable regulatory standards and provide training
- check_circleOversee EMC, environmental, and IEC 60601-1 compliance testing at certified labs
- check_circleAct as liaison with regulatory agencies such as UL, CSA, TUV, and BSI
- check_circleDrive compliance activities for new product launches, post-launch changes, and corrective actions
- check_circleSupport internal and third-party audits and prepare documentation for test labs and regulatory bodies
- check_circleCreate compliance program plans, certification test plans, verification procedures, and reports
Requirements
- verifiedBachelor's degree required; Master's or PhD in technical field preferred
- verified8+ years experience in compliance testing (or 6+ with Master's, 3+ with PhD)
- verifiedExperience with wireless technologies (Wi-Fi, RFID)
- verifiedExperience with electrical test equipment (spectrum analyzers, vector network analyzers, signal generators)
- verifiedProficiency in EMC design concepts and lab test equipment
- verifiedProficiency in revision control and at least one software language (e.g., Python)
- verifiedFamiliarity with FDA, FAA, DoD, ISO environments and risk assessment management
- verifiedProficiency in Microsoft Office Suite
Nice to Have
Master's or PhD in a technical field. Ability to mentor and train junior engineers.
Benefits & Perks
check_circleComprehensive training upon joining and continued development throughout career
Similar Job Opportunities
Skills, education and keywords
Skills: Iso, FCC, Ul, Ieee, Eu MD, Emc, Emi, Iec 60601-1, Wireless Technologies, Wi-Fi.
Education: Bachelor's degree required; Master's in a technical field strongly preferred; PhD in a technical field strongly preferred.
Frequently asked questions about Lead Compliance Engineer, R&D at Hologic, Inc.
What does a Lead Compliance Engineer, R&D at Hologic, Inc. do?expand_more
Day-to-day, the Lead Compliance Engineer, R&D at Hologic, Inc. will develop and implement compliance strategies for global regulatory standards throughout the product lifecycle; serve as the primary technical expert for regulatory compliance supporting r&d and program management teams; participate in product design reviews to identify applicable regulatory standards and provide training; and oversee emc, environmental, and iec 60601-1 compliance testing at certified labs.
What are the requirements for this Lead Compliance Engineer, R&D role?expand_more
To qualify for the Lead Compliance Engineer, R&D at Hologic, Inc. position, applicants should have: Bachelor's degree required; Master's or PhD in technical field preferred; 8+ years experience in compliance testing (or 6+ with Master's, 3+ with PhD); Experience with wireless technologies (Wi-Fi, RFID); Experience with electrical test equipment (spectrum analyzers, vector network analyzers, signal generators); Proficiency in EMC design concepts and lab test equipment; and Proficiency in revision control and at least one software language (e.g., Python).
Where is the Lead Compliance Engineer, R&D role at Hologic, Inc. located?expand_more
Lead Compliance Engineer, R&D at Hologic, Inc. is based in 224, Ridge Way, Glasgow Pines, New Castle County, Delaware, 19702, United States. This is a on-site role.
Is this Lead Compliance Engineer, R&D job remote, hybrid, or on-site?expand_more
Hologic, Inc. has listed this Lead Compliance Engineer, R&D role as on-site.
How much experience is required for this Lead Compliance Engineer, R&D role?expand_more
Lead Compliance Engineer, R&D at Hologic, Inc. typically requires 8+ years of relevant experience at the lead level.
What skills do you need for the Lead Compliance Engineer, R&D role at Hologic, Inc.?expand_more
Key skills for Lead Compliance Engineer, R&D at Hologic, Inc. include Iso; FCC; Ul; Ieee; Eu MD; Emc; Emi; and Iec 60601-1.
What education is required for Lead Compliance Engineer, R&D at Hologic, Inc.?expand_more
Educational requirements for this role: Bachelor's degree required; Master's in a technical field strongly preferred; and PhD in a technical field strongly preferred.
What category does the Lead Compliance Engineer, R&D role belong to?expand_more
Lead Compliance Engineer, R&D at Hologic, Inc. is part of the engineering job category on Recrutus.