Compliance Engineer
Core
Own hardware compliance and product safety certification for handheld medical ultrasound devices across electrical, mechanical, firmware, and software domains.
Role type
Senior IC compliance engineer (medical devices)
Builds
FDA, Health Canada, EU MDR, FCC, ISED/IC, and CE/RED certified medical ultrasound devices
Domain
Medical devices / Hardware compliance (via careerplan.io/jobs/D7-009-92-F62-compliance-engineer-at-clarius-mobile-health)
Required skills
IEC 60601 suite knowledge, EMC testing execution, wireless regulatory certification, risk management (ISO 14971), usability engineering (IEC 62366-1), biocompatibility evaluation (ISO 10993), circuit schematic interpretation, test equipment proficiency
Preferred skills
Medical device industry experience, vendor management, regulatory submission support
Technologies
Spectrum analyzers, EMI receivers, LISNs, hipot/leakage testers, oscilloscopes
Responsibilities
Plan and manage EMC compliance testing to IEC 60601-1-2; Manage electrical safety testing to IEC 60601-1/-1-11/-1-12; Plan and manage mechanical safety testing; Own radio and wireless regulatory testing (FCC, ISED/IC, CE/RED); Develop risk management and usability engineering documentation; Coordinate biocompatibility evaluation; Support regulatory submissions with compliance evidence; Perform pre-compliance measurements and design reviews; Interface with external test laboratories and notified bodies.
Seniority
Mid-Senior, hands-on IC
