Lead Compliance Engineer, R&D
On-site · Newark, Delaware, United States
Job Summary
Lead Compliance Engineer, R&D role focused on defining and executing product compliance strategies for global medical devices. Responsible for regulatory standards (EU MDR, EMC/EMI, safety standards), coordinating internal/external testing with labs and regulators (UL, CSA, TUV, BSI; ISO, FCC, IEC 60601-1), and integrating compliance requirements into product definitions. Leads cross-functional teams through product design reviews, prepares certification plans and documentation, mentors junior engineers, and supports audits and CAPA activities across the product lifecycle. Requires deep knowledge of medical device regulatory landscapes, wireless testing, lab equipment proficiency, and strong communication across engineering, manufacturing, and marketing teams.
Required Qualifications
- Bachelor’s degree required; Master’s or PhD 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)
- 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
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