Description • Full-time, hands-on role inventing practical solutions to develop top-tier medical imaging hardware • Write and manage technical specifications (system, subsystem, and interface specs) and trace requirements through design, verification, and validation. • Drive compliance testing strategy and execution for IEC 60601-1 electrical safety and IEC 60601-1-2 EMC requirements; coordinate lab testing, pre-compliance, and corrective actions. Plan and execute subsystem tests, systems integration and testing, and formal verification tests for medical devices • Support existing released products with root cause failure analysis, redesign for cost reduction, and iterations based on market feedback • Support manufacturing troubleshooting and complaints investigations as required • Lead communication with remote teams as Systems Engineering lead • Work effectively in cross-functional teams consisting of Research, Engineering, QA/RA, Marketing, Operations, Finance and other functions as a team player • Contribute to intellectual property creation and documentation • Coach and delegate tasks to junior associates Requirements • Bachelor's degree in electrical engineering (BSEE) or related field required, with 8+years of work experience in medical device industry • Strong understanding of ISO 13485, IEC 60601-1, 3.1 edition Safety and Essential performance and IEC60601-1-2 4th edition Electromagnetic disturbances • Strong skills in system architecture, requirements management, and specification writing. • Experience with photonic/optical system design and development is a plus • Familiarity with risk management (ISO 14971) and design control processes (21 CFR 820 / MDR equivalents). • Must have experience integrating, testing, and verifying complex medical systems • Experience with schematic capture, PCBA design and testing, motion control system is a plus • Extensive experience working with consultants, outside partners, contract manufacturers and suppliers • Ability to independently organize/align project tasks with department/corporate priorities