Senior IEC 60601 Compliance Engineer — Medical Devices

Boston Scientific; Maple Grove (MN); Hybrid; USD 85,000 - 162,000; Full time

Job summary

Boston Scientific in Maple Grove, MN is seeking a Senior R&D Compliance Engineer to lead IEC 60601 product safety and compatibility activities for both new and sustaining products. You will apply established and emerging technologies to help deliver safe, effective medical devices that advance the company’s mission for patients and clinicians.

You will collaborate with engineering, quality, regulatory, clinical, and supplier teams to ensure compliance, maintain documentation, and champion

Qualifications

• Bachelor’s degree in electrical, computer, mechanical, or related engineering 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.

Responsibilities

• 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.

Skills

IEC 60601-1 expertise

IEC 60601-1-2 experience

Cross-functional coordination

Education

Bachelor’s degree in engineering (electrical / computer / mechanical) with 3+ years experience

Tools

Windchill

CAD drawings

Job description

Boston Scientific in Maple Grove, MN is seeking a Senior R&D Compliance Engineer to lead IEC 60601 product safety and compatibility activities for both new and sustaining products. You will apply established and emerging technologies to help deliver safe, effective medical devices that advance the company’s mission for patients and clinicians.

You will collaborate with engineering, quality, regulatory, clinical, and supplier teams to ensure compliance, maintain documentation, and champion