Sr. Electrical Engineer; IEC Compliance

Sr. Electrical Engineer (IEC Compliance)

Medford, MA $-$

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them 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 & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

The Compliance Engineer R&D 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 is the technical subject matter expert for regulatory compliance. Participates in product design reviews, identifies and interprets applicable regulatory standards and requirements;

provides guidance and training to prevent compliance issues from the initial product design throughout production and delivery of the final product. May assist in the development of testing tools and product test plans to ensure effective compliance testing. Coordinates both internal testing and testing at outside labs, certification labs and maintains all documentation. Ensures suppliers comply with domestic and international requirements.

The Compliance Engineer R&D having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Some barriers to entry exist at this level (e.g., dept/peer review). Determines methods and procedures on new assignments and may coordinate activities of other personnel (Team Lead).

• 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. Leverages in-depth knowledge of client’s products and the product lifecycle.
• 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.
• As a subject matter expert, participates 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.
• 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 as well as sustaining maintenance of business. Responsible for reporting status of compliance activities.
• Supports Marketing & Regulatory’s 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.
• Oversee EMC, & 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.
• 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 product certifications, through 3rd party testing, to required standards.
• Responsible for product post‑launch changes (e.g., regulatory changes, product evolution, corrective actions) to ensure on‑going compliance.
• Support UL inspection audits, support Quality team during Certified Body audits for Compliance…