Medical Device Compliance Engineer — IEC 60601 Expert

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

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.