Principal Compliance Engineer
Boston Scientific
Summary
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.
Job description
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.
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.
Benefits
- Health insurance
- Annual bonus target
- Long-term incentives
Company overview
Boston Scientific Corporation is a global leader in the development, manufacturing, and marketing of minimally invasive medical devices used in interventional medical specialties. Founded in 1979 and headquartered in Marlborough, Massachusetts, the company focuses on transforming patient lives through innovative medical solutions across a wide range of therapeutic areas including cardiology, endoscopy, urology, pulmonology, and neuromodulation. With approximately 53,000 employees worldwide and operations in 40 countries, Boston Scientific serves over 44 million patients annually. The company invests heavily in research and development, allocating $1.6 billion to R&D in 2024, and maintains a strong commitment to quality, patient safety, and meaningful innovation. Boston Scientific's product portfolio includes advanced technologies such as cardiac rhythm management devices, coronary stents, ablation systems, endoscopy equipment, and neuromodulation therapies, all designed to improve patient outcomes and quality of life through less invasive treatment options.