Sr. R&D Compliance Engineer

Nalu Medical; Maple Grove (MN); Hybrid; USD 85,000 - 162,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Boston Scientific in Maple Grove, MN is seeking a Senior R&D Compliance Engineer to lead IEC 60601 safety and compliance activities for new product development and sustaining engineering. You will ensure patient safety and product quality while collaborating across engineering, quality, regulatory, sourcing, and manufacturing teams.

The role requires a solid background in IEC 60601-1, experience with IEC 60601-1-2 and EMC, and strong cross-functional coordination with NRTL labs.

Qualifications

• Bachelor's degree in electrical, computer, mechanical, or related engineering with 3 years of experience; or a master's with 1 year.
• Subject-matter expertise in IEC 60601-1 and experience with IEC 60601-1-2.
• EMC expertise is preferred but not required.
• Self-directed, cross-functional coordination with NRTLs to meet project needs.

Responsibilities

• Lead IEC 60601-1 product safety planning, protocol development, testing and reporting.
• Coordinate with NRTL labs on quotations, test planning and schedules.
• Evaluate changes to international standards and impact on products.
• Communicate compliance status, risks and decisions to stakeholders.
• Partner with engineering, quality, sourcing, regulatory and manufacturing to achieve IEC 60601 compliance.
• Provide technical guidance and direction to technicians and engineers as needed.
• Analyze complex issues and recommend corrective actions.
• Champion patient safety and product quality through quality processes.

Skills

IEC 60601-1

IEC 60601-1-2

EMC expertise

Cross-functional coordination

NRTL coordination

Communication

Problem solving

Education

Engineering degree (Electrical/ Computer/ Mechanical or related)

Tools

Windchill

CAD drawings

Electrical schematics

BOM management

Manufacturing/supplier transfers

Job description

Additional Location(s): N/A

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 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.

Work model, sponsorship, relocation:

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.

Your responsibilities 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.

Required Qualifications:

• 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.

Preferred Qualifications

• 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 ID: 634219

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 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 rolesmay 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 by providing a 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, neurological and 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 specific prohibited substance test 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.