Lead Compliance Engineer, R&D

Hologic•Newark, DE

1d•$111,400 - $174,300•Onsite

About The Position

Hologic is seeking a talented Lead Compliance Engineer to join their Research & Development (R&D) team. This role is responsible for driving product compliance for global markets, ensuring Hologic’s medical products meet regulatory standards and achieve necessary certifications. The Lead Compliance Engineer will act as a technical subject matter expert, collaborating with regulatory agencies, participating in product design reviews, and guiding cross-functional teams from initial design through production and delivery. Responsibilities include overseeing compliance testing, maintaining documentation, ensuring supplier adherence to requirements, resolving complex issues, and potentially coordinating other personnel as a team lead.

Requirements

Bachelor’s degree required.
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).

Nice To Haves

Master’s or PhD in a technical field strongly preferred.
Ability to mentor and train junior engineers is a plus.

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, 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.