Principal Compliance Engineer
Core
Lead IEC 60601 product safety and electromagnetic compatibility compliance activities for new product development of medical devices.
Role type
Principal R&D Compliance Engineer
Builds
Safe, effective medical devices for patients and clinicians
Domain
Medical devices / Regulatory compliance
Required skills
IEC 60601 standards expertise, test planning, protocol development, cross-functional collaboration, technical risk assessment, corrective action analysis
Preferred skills
Master's degree in engineering, experience with Nationally Recognized Testing Laboratories (NRTLs)
Technologies
IEC 60601, NRTL testing protocols
Responsibilities
Lead IEC 60601 compliance activities including test planning, protocol development, execution and reporting; Coordinate with third-party NRTLs on quotations, purchase orders, test planning and schedules; Evaluate changes to international standards and assess their impact on existing and new products; Analyze complex engineering challenges and recommend effective corrective actions or alternative solutions; Provide technical guidance, training and work direction to technicians, interns and engineers as needed; Champion patient safety and product quality by adhering to applicable quality processes, procedures and regulatory requirements
Seniority
Principal, hands-on IC with mentorship