ECI · 6 hours ago
Sr. R&D Engineer (Compliance) - Medical Device #8032
Marlborough, MA
Full-time
Onsite
Senior Level
6+ years expECI is a global leader in professional consulting services for the life sciences industry. The Compliance Engineer R&D defines and executes product compliance strategies to ensure that products meet regulatory standards and compliance certifications for global markets, while also providing guidance and support to various teams throughout the product lifecycle.
BiotechnologyConsultingLife ScienceProject Management
No H1B
U.S. Citizen Only
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
Required
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
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
Preferred
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 a must - e.g., Python
Familiar with government-regulated and/or certified engineering environments (FDA, FAA, DoD, ISO, etc.)
Company
ECI
ECI (Enhanced Compliance Inc.) stands as a beacon of excellence in the life sciences consulting arena.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Michael Boyer
Chief Financial Officer
Shital Patel
Chief Operating Officer
Company data provided by crunchbase