Systems Engineer (onsite)

Nevro (NYSE: NVRO) is a global medical device company headquartered in Redwood City, California. We are focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. The company started with a simple mission to help more patients suffering from debilitating pain and developed its proprietary 10 kHz Therapy™, an evidence-based, non-pharmacologic innovation that has impacted the lives of more than 100,000 patients globally.

Nevro’s comprehensive HFX™ spinal cord stimulation (SCS) platform includes a Senza SCS system and support services for the treatment of chronic trunk and limb pain and painful diabetic neuropathy.  Senza®, Senza II®, Senza Omnia™, and Senza HFX iQ™ are the only SCS systems that deliver Nevro's proprietary 10 kHz Therapy. HFX iQ, Nevro’s latest innovation, is the first and only SCS System that uses Artificial Intelligence to optimize and maintain pain relief using each patient's response¹. Nevro’s unique support services provide every patient with an HFX Coach™ throughout their pain relief journey and every physician with HFX Cloud™ insights for enhanced patient and practice management. 

Systems 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

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

 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. 

100,000-150,000

Nevro offers equal employment opportunity, regardless of race, color, creed, religion, national origin, marital or family status, sex, sexual orientation, gender expression (including religious dress and grooming practices), gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), physical or mental condition, protected veteran status, disability, age or other characteristics protected by laws.