Sr. R&D Engineer; Compliance - Medical Device

Sr. R&D Engineer (Compliance) - Medical Device #8032

Join the team in Wilmington, DE to execute product compliance strategies and lead regulatory initiatives for a global medical device organization. This role EP focuses on ensuring products meet regulatory standards (ISO, UL, FCC, IEEE) and managing compliance testing and certification.

• Accountable for ensuring client's products meet all applicable EMC/EMI and safety compliance standards for our global markets throughout the product lifecycle – including design for compliance, certification, and global regulatory compliance such as EU MDR.
• Functions as go-to technical expert and provides guidance to Program Management, Regulatory Assurance, and other R&D functions. Supports lower-level compliance engineers with technical inquiries.
• Participates in product technical reviews and testing to identify areas of risk for compliance, troubleshoot compliance issues, and provide recommendations to improve designs for compliance considerations.
• Key contributor to the Project Core Team and drives compliance efforts for products in regard to safety and EMC requirements through all product design/development phases with reporting of compliance status.
• Supports Marketing & Regulatory efforts to identify applicable regulatory compliance requirements and provide technical translation of requirements to R&D teams.
• Partners with Marketing, Systems, and Engineering teams to implement requirements into product definitions.
• Performs or guides the creation of Compliance Program Plans.
• Oversees EMC & environmental pre‑compliance and compliance testing at certified test labs.
• Oversees IEC 60601‑1 compliance testing.
• Acts as the client's compliance liaison to test labs and certified agencies (UL, CSA, TUV, BSI).
• Responsible for EMC & safety certification test plans, verification procedures, and reports.
• Responsible for compliance re‑testing needs based on design changes.
• Responsible for pre‑product launch certifications through third‑party testing to required standards.
• Responsible for post‑launch changes (regulatory changes, product evolution, corrective actions) to maintain ongoing compliance.
• Supports UL inspection audits and Quality team during certified body audits for compliance evidence on products.
• Prepares and reviews documentation for test labs, notified bodies, and other governing regulatory bodies.
• Creates schedules and budgetary inputs for compliance testing and certifications.
• Maintains objective evidence of compliance to applicable regulatory requirements.
• Reviews and critiques test reports generated by test agencies/labs.
• Works collaboratively with all functions and team members – program management, field service, manufacturing, electrical, mechanical, compliance, and reliability engineers.
• Manages multiple projects and priorities defined by program or functional management.
• Key contributor in CAPA projects and VIP projects, cost reduction projects, EOL projects, and operations requests for support.

• Preferred Minimum Non‑Technical Degree: 8+ Years
• Preferred Minimum Technical/Advanced Degree: 6+ Years with Master's Degree, 3+ Years with PhD
• Experience with compliance testing in a product device field and international certifications.
• Experience with wireless technologies including Wi‑Fi and RFID.
• Experience working with electrical test equipment including spectrum analyzers, vector network analyzers, and signal generators is beneficial. Experience leading cross‑functional teams and projects is beneficial.
• Proficiency in at least one software language – e.g., Python.
• Familiar with government‑regulated and/or certified engineering environments (FDA, FAA, DoD, ISO, etc.).

Mid‑Senior level

Full‑time

Engineering and Information Technology

Business Consulting and Services

Wilmington, DE

$‑$ (2 months ago)

All qualified applicants will receive consideration for employment at ECI without regard to race, creed, color, religion, national origin, sex, age, disability, sexual orientation, gender identity or expression, genetic predisposition or carrier status, veteran, marital, or citizenship status or any other status protected by law. At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment‑based visa sponsorship now or in the future.

At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.