Sr. R&D Compliance Engineer
Boston Scientific
Summary
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 compatibility 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.
Job description
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.
Requirements
- 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.
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.