Principal Compliance Engineer

Boston Scientific; Maple Grove (MN); Hybrid; USD 102.000 - 194.000; Vollzeit

Zusammenfassung

Boston Scientific seeks a Principal R&D Compliance Engineer to lead IEC 60601 compliance for new product development and to guide EMC strategies. You will work with cross-functional teams to ensure safety, performance, and regulatory alignment across medical devices.

The role emphasizes collaboration with engineering, quality, regulatory, and suppliers, driving timely compliance actions and patient safety.

Qualifikationen

• Bachelor's degree in electrical, biomedical, mechanical or related engineering with 5+ years in field; or Master's with 3+ years.
• Subject matter expertise in IEC 60601 standards and compliance requirements.
• Experience applying IEC 60601-1-2 EMC standards.

Aufgaben

• Lead IEC 60601 compliance activities for new product development, incl. test planning and reporting.
• Coordinate with third-party NRTL labs on quotations, test planning and schedules.
• Evaluate changes to international standards and their impact on products.
• Communicate compliance status and risks to project stakeholders.
• Collaborate with cross-functional teams to achieve IEC 60601 compliance.
• Provide technical guidance and direction to technicians and engineers.
• Analyze complex engineering challenges and recommend corrective actions.
• Champion patient safety and product quality per regulatory requirements.

Kenntnisse

IEC 60601

EMC expertise

Cross-functional

NPD support

Ausbildung

Bachelor's in electrical/biomedical/mechanical

Master's degree

Tools

Windchill

Jobbeschreibung

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 role:

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.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our Maple Grove, MN site 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.

Your responsibilities will include:

• 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.

Required qualifications:

• 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.

Preferred qualifications:

• 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.

Minimum Salary:$102100

Maximum Salary: $194000

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).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life byprovidinga broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological,neurologicaland urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn .

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specificprohibited substancetest requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

Nearest Major Market: Minneapolis
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