Staff Compliance Engineer - Test and Certification
Core
Lead product safety, compliance, and certification activities for new product development and sustainment projects, working with cross-functional teams and external laboratories.
Role type
Staff Compliance Engineer (Test and Certification)
Builds
Certified medical devices and safety-compliant products for global markets
Domain
Medical device industry + Electrical/Mechanical safety compliance
Required skills
Electrical engineering, product safety, compliance testing, EMC testing, failure analysis, root cause analysis, regulatory audit support, laboratory equipment operation
Preferred skills
Medical device development, IEC 60601-1/1-2 certification, ISO 14971 risk management, ISO 13485/9001 quality systems
Technologies
Oscilloscopes, signal generators, power analysers
Responsibilities
Lead product safety and certification activities; Develop and execute safety/performance test plans; Partner with engineering teams to resolve compliance risks; Lead technical design reviews and failure investigations; Coordinate with third-party labs and certification bodies; Analyze test data to identify root causes; Support regulatory audits; Act as technical point of contact for compliance.
Seniority
Staff, hands-on IC with strategic oversight