Job Summary
& ResponsibilitiesSystems Engineer, Medical Device, Redwood City, CA- Ensure the logical and systematic conversion of customer requirements and performance requirements into systems solutions that account for technical, cost and schedule constraints for RF communications systems and active implantable systems. Collaborate with cross-functional stakeholders to identify design inputs (user needs and system requirements). Evaluate technical, scheduling, and resource tradeoffs when generating requirements for project. Ensure requirements are correct, complete, unambiguous, and testable, and provide sufficient detail for tracing to subsystem and module level requirements. Document design inputs into requirements tracking system for tracking and traceability. Utilize IEC 62366, ANSI/AAMI HE75, and FDA Guidance for Human Factors and Usability Engineering. Perform human factors engineering across the product lifecycle including identification of customer user needs and use scenario, definition of use specifications (user profiles, user environments) and user interface requirements. Assist with generation of deliverables for compliance with IEC 60601, IEC 62366, IEC 62304, ISO 14708, ANSI/AAMI HE75, and FDA Guidance for Human Factors and Usability Engineering, including working with external vendors as necessary. Investigate and define systems engineering requirements for new algorithms or features. Perform Risk management using risk analysis, FMEA, or ISO 14971. Perform engineering tasks including definition, verification, or product development of a system, and drive them to on-time, high quality completion. Perform hands-on system integration testing and troubleshooting of technical issues. Perform system level verification against requirements. Create test plans, procedures and reports, perform and analyze system setup, and conduct verification and validation activities. Hybrid work is permitted per employer’s discretion. (No agencies or phone calls please.) #LI-DNI
Role Requirements
Must possess 3 years’ experience with the following:
- Development in a regulated industry such as medical device, defense, or automotive
- Compliance with one or more of the following relevant standards: IEC 60601, ISO 14708, or IEC 62304
- Risk management (risk analysis, FMEA, or ISO 14971)
- One or more of the following: IEC 62366, ANSI/AAMI HE75, and FDA Guidance for Human Factors and Usability Engineering
Skills and Knowledge
Requires Master’s degree Electrical Engineering, Computer Engineering, Biomedical Engineering, Systems Engineering, or a related field and 3 years of experience as biomedical engineer, systems engineer or related engineering role or Bachelor’s degree in Electrical Engineering, Computer Engineering, Biomedical Engineering, Systems Engineering, or a related field and 5 years of experience as biomedical engineer, systems engineer or related engineering role.
Target Pay Range
100,000-150,000
Systems Engineer (onsite) • Redwood City, CA, US
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