Hologic, Inc. · 6 hours ago
Lead Compliance Engineer, R&D
Newark, DE
Full-time
Onsite
Senior Level, Lead/Staff
$111K/yr - $174K/yr
8+ years expHologic, Inc. is a global leader in medical device innovation, dedicated to improving lives through advanced technology and rigorous quality standards. They are seeking a Lead Compliance Engineer to define and execute product compliance strategies, ensuring that medical products meet regulatory standards and achieve necessary certifications. The role involves working with regulatory agencies, overseeing compliance testing, and guiding cross-functional teams throughout the product lifecycle.
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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 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 CAPA, cost reduction, EOL, and operations support projects
Mentor and train junior engineers as needed
Qualification
Required
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)
Preferred
Ability to mentor and train junior engineers is a plus
Benefits
Competitive salary
Annual bonus scheme
Comprehensive training
Continued development and training
Company
Hologic, Inc.
We’re an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day.
5001-10000 employees
H1B Sponsorship
Hologic, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (31)
2024 (20)
2023 (15)
2022 (32)
2021 (20)
2020 (14)
Funding
Current Stage
Public CompanyTotal Funding
$2.87B2025-10-21Private Equity
2025-10-21Acquired
2025-07-15Post Ipo Debt· $2.42B
Leadership Team
Stephen MacMillan
Chairman President & CEO
Karen Harrington
Director Scientific Affairs
Recent News
2026-01-17
Company data provided by crunchbase