Develop and manage technical specifications for medical imaging hardware. Conduct compliance testing, support existing products, and lead cross-functional teams.
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
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