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ECI · 1 day ago

Sr. Electrical Engineer (IEC Compliance)

Marlborough, MA

Full-time

Onsite

Senior Level

6+ years exp

ECI is a global leader in professional consulting services for the life sciences industry, focused on providing transformative solutions. The Sr. Electrical Engineer (IEC Compliance) will define and execute product compliance strategies to ensure that products meet regulatory standards and certifications, working closely with regulatory agencies and providing guidance throughout the product lifecycle.

BiotechnologyConsultingLife ScienceProject Management

Growth Opportunities

No H1B

Hiring Manager

Brittney Cowens

Responsibilities

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 evidence on products

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

Work collaboratively with all functions and team members – e.g. program management, field service, manufacturing, electrical, mechanical, compliance and reliability engineers

Manage 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 request for support

Qualification

IEC 60601-1 complianceEMC/EMI complianceCompliance testingWireless technologiesElectrical test equipmentSoftware proficiencyRegulatory compliance knowledgeCross-functional team leadershipDocumentation preparation