Medical Imaging Hardware Systems EngineerFull-time, hands-on role inventing practical solutions to develop top-tier medical imaging hardwareWrite 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 devicesSupport existing released products with root cause failure analysis, redesign for cost reduction, and iterations based on market feedbackSupport manufacturing troubleshooting and complaints investigations as requiredLead communication with remote teams as Systems Engineering leadWork effectively in cross-functional teams consisting of Research, Engineering, QA/RA, Marketing, Operations, Finance and other functions as a team playerContribute to intellectual property creation and documentationCoach and delegate tasks to junior associatesBachelor's degree in electrical engineering (BSEE) or related field required, with 8+years of work experience in medical device industryStrong understanding of ISO 13485, IEC 60601-1, 3.1 edition Safety and Essential performance and IEC60601-1-2 4th edition Electromagnetic disturbancesStrong skills in system architecture, requirements management, and specification writing.Experience with photonic/optical system design and development is a plusFamiliarity with risk management (ISO 14971) and design control processes (21 CFR 820 / MDR equivalents).Must have experience integrating, testing, and verifying complex medical systemsExperience with schematic capture, PCBA design and testing, motion control system is a plusExtensive experience working with consultants, outside partners, contract manufacturers and suppliersAbility to independently organize/align project tasks with department/corporate priorities