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 device hardware compliance and regulatory certification (via careerplan.io/jobs/D7-009-92-F62-compliance-engineer)
Required skills
IEC 60601 suite knowledge, EMC testing execution, wireless regulatory certification, risk management documentation, usability engineering documentation, biocompatibility evaluation, test plan authoring, circuit schematic interpretation, test equipment proficiency
Preferred skills
Medical device industry experience, vendor management, regulatory strategy, ISO 13485 QMS familiarity
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 documentation per ISO 14971; Develop usability engineering documentation per IEC 62366-1; Coordinate biocompatibility evaluation per ISO 10993; Support regulatory submissions with compliance evidence; Perform pre-compliance measurements and design reviews; Interface with external test laboratories and notified bodies.
Seniority
Mid-level, hands-on IC
