Principal Medical Device Compliance Engineer IEC 60601

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

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.