Principal Compliance Engineer

Boston Scientific•Maple Grove, MN
•$102,100 - $194,000•Hybrid

About The Position

Boston 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 Boston Scientific's Interventional Therapies division as a Principal R&D Compliance Engineer, supporting new product development (NPD) and leading IEC 60601 product safety and electromagnetic compatibility compliance activities. In this role, you will apply established and emerging technologies to help deliver safe, effective medical devices that advance our mission to improve patient lives. You will collaborate with cross-functional teams, provide technical expertise and drive compliance strategies that support innovative medical technologies for patients and clinicians.

Requirements

  • Bachelor's degree in electrical, biomedical, mechanical or a related engineering discipline with a minimum of 5 years' experience in a relevant engineering field; or a master's degree with a minimum of 3 years' experience in a relevant engineering field.
  • Demonstrated subject matter expertise in IEC 60601 standards and compliance requirements.
  • Experience applying IEC 60601-1-2 standards for electromagnetic compatibility (EMC).
  • Demonstrated ability to work independently, take initiative and proactively coordinate cross-functional teams and external testing laboratories to meet project objectives.

Nice To Haves

  • Experience applying IEC 60601-1-12 (Emergency Medical Services Environment) and RTCA DO-160 (Environmental Conditions and Test Procedures for Airborne Equipment).
  • Strong organizational, communication and collaboration skills.
  • Experience with medical device design controls and documentation management systems, such as Windchill.
  • Experience with medical capital equipment, including medical electrical equipment and systems.
  • Experience interpreting CAD drawings or electrical schematics, managing bills of materials and supporting manufacturing or supplier transfers.
  • Ability to synthesize complex technical information, draw sound conclusions and develop well-supported recommendations.
  • Advanced expertise in electromagnetic compatibility (EMC) testing and compliance.

Responsibilities

  • Lead IEC 60601 compliance activities for new product development, including test planning, protocol development, execution and reporting.
  • Coordinate with third-party Nationally Recognized Testing Laboratories (NRTLs) on quotations, purchase orders, test planning and schedules.
  • Evaluate changes to international standards and assess their impact on existing and new products.
  • Communicate compliance status, technical risks and key decisions clearly and promptly to project stakeholders.
  • Collaborate with engineering, quality, sourcing, purchasing, manufacturing, regulatory, clinical, marketing and other cross-functional teams 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 challenges and recommend effective corrective actions or alternative solutions.
  • Champion patient safety and product quality by adhering to applicable quality processes, procedures and regulatory requirements.

Benefits

  • The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role.
  • Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.
  • At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.
  • Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
  • Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
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