Sr. R&D Compliance Engineer
Listed on 2026-10-12
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Engineering
Biomedical Engineer, Medical Device Industry, Systems Engineer, Electrical Engineering
Diversity
- Innovation
- Caring
- Global Collaboration
- Winning Spirit
- High Performance
At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.
About the RoleBoston Scientific was recognized by Forbes as one of the Best Workplaces for Engineers in 2026, reflecting a culture where engineers do meaningful work.
Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.
Join the Interventional Cardiology & Vascular Therapies division as a Senior R&D Compliance Engineer supporting new product development and sustaining engineering. In this role, you will lead IEC 60601 product safety and compliance activities.
You will apply established and emerging technologies to help deliver safe, effective medical devices that advance Boston Scientific's mission for patients and clinicians.
At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our Maple Grove, MN office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.
Yourresponsibilities will include:
- Lead IEC 60601-1 product safety planning, protocol development, testing, and reporting for new and sustaining products.
- Coordinate with third-party Nationally Recognized Testing Laboratories (NRTL’s) on quotations, purchase orders, test planning, and schedules.
- Evaluate changes to international standards and determine their impact on company products.
- Communicate compliance status, risks, and decisions clearly and promptly to stakeholders.
- Partner with engineering, quality, sourcing, purchasing, manufacturing, regulatory, clinical, marketing, and other functions to achieve project objectives and IEC 60601 compliance.
- Provide technical guidance, training, and work direction to technicians, interns, and engineers as needed.
- Analyze complex engineering issues and recommend effective corrective or alternative actions.
- Champion patient safety and product quality by adhering to all applicable quality processes and procedures.
- Bachelor’s degree in electrical, computer, mechanical, or a related engineering discipline with 3+ years of relevant experience; or a master’s degree with 1+ years of relevant experience.
- Subject-matter expertise in IEC 60601-1.
- Experience applying IEC 60601-1-2; advanced EMC expertise is preferred but not required.
- Self-directed, proactive approach to coordinating cross-functional teams and NRTLs to meet project needs.
- Strong organizational, communication, and collaboration skills.
- Experience with medical device design controls and documentation systems, such as Windchill.
- Experience with medical capital equipment, including medical electrical equipment and systems.
- Experience with CAD drawings or electrical schematics, bill-of-materials management, and manufacturing or supplier transfers.
- Ability to synthesize diverse technical inputs, draw sound conclusions, and make well-supported recommendations.
Requisition
Minimum Salary:$85000
Maximum Salary: $161500
The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see — will vary based on actual location of…
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