Sr. Electrical Engineer ( IEC Compliance - Medical Device

Sr. Electrical Engineer ( IEC Compliance) - Medical Device #3356

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ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients rely on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in delivering transformative solutions with distinctive, sustainable, and long‑term value. ECI boasts a proven track record of providing full product life‑cycle consulting on a variety of challenging and exciting projects.

Our collaborative culture, welcoming team, and flexible employment and benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

The Compliance Engineer defines and executes product compliance strategies, policies and processes to ensure that the company’s products meet regulatory standards and compliance certifications are obtained and maintained for global markets (e.g., ISO, FCC, UL, IEEE). This individual works closely with regulatory agencies and serves as the technical subject‑matter expert for regulatory compliance. The role participates in product design reviews, identifies and interprets applicable regulatory standards and requirements, and provides guidance and training to prevent compliance issues from initial product design through production and delivery of the final product.

The engineer may assist in developing testing tools and product test plans, coordinate both internal and external testing, maintain all documentation, and ensure suppliers comply with domestic and international requirements.

• Ensure client products meet all applicable EMC/EMI and safety compliance standards for global markets throughout the product lifecycle—including design for compliance, certification, and global regulatory compliance such as EU MDR.
• Act as the go‑to technical expert and provide guidance to Program Management, Regulatory Assurance, and other R&D functions. Support lower‑level compliance engineers with technical inquiries.
• Participate in product technical reviews and testing to identify areas of risk for compliance, troubleshoot compliance issues, and recommend design improvements.
• Contribute to the Project Core Team, driving compliance efforts for products in all stages of design/development and sustaining maintenance of business, reporting status of compliance activities.
• Support Marketing & Regulatory’s efforts to identify applicable regulatory requirements and translate them to R&D teams.
• Partner with Marketing, Systems, and Engineering teams to implement requirements into product definitions.
• Perform or guide the creation of Compliance Program Plans.
• Oversee EMC and environmental pre‑compliance and compliance testing at certified test labs.
• Oversee IEC 60601‑1 compliance testing.
• Act as the client’s compliance liaison to test labs and certified agencies (e.g., UL, CSA, TUV, BSI).
• Prepare and review documentation for test labs, notified bodies, and other governing regulatory bodies.
• Create schedules and budgetary inputs for compliance testing and certifications.
• Maintain objective evidence of compliance to applicable regulatory requirements.
• Review and critique test reports generated by test agencies/labs.
• Collaborate with all functions and team members—program management, field service, manufacturing, electrical, mechanical, compliance, and reliability engineers.
• Manage multiple projects and priorities defined by program or functional management.
• Contribute to CAPA projects, 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 such as spectrum analyzers, vector network analyzers, and signal…