Systems Engineer III
US-CA-Redwood City
Job ID: 2024-4461
Type: Regular Full-Time
Category: Research & Development
HQ
Overview
The Systems Engineer III will play a key role in the development of a Class III implantable Neuromodulation system for pain management, working cross functionally to help define systems and ensure that all stakeholders are aligned, and user needs are met. In this role, you will be a highly productive member of the technical team to help make key and impactful decisions.
- Ensure the logical and systematic conversion of customer requirements and performance requirements into systems solutions that account for technical, cost and schedule constraints.
- Assist with investigation and definition of systems engineering requirements for new algorithms or features, and facilitates the transition of algorithms into new projects through clinical review and evaluation.
- Owns tasks within a larger effort such as definition, verification or product development of a system, and drives them to on-time, high quality completion.
- 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 62366, ANSI/AAMI HE75, and FDA Guidance for Human Factors and Usability Engineering, including working with external vendors as necessary.
- Assist with generation of cybersecurity deliverables for compliance with MDCG 2019-16, FDA Guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, and FDA Guidance Postmarket Management of Cybersecurity in Medical Devices.
- Performs hands-on system integration testing and troubleshooting of technical issues. Works with development team to identify root cause and viable resolutions for issues.
- Performs system level verification against requirements. Creates test plans, procedures and reports, performs and analyzes system set up, and conducts verification and validation activities.
- Provide technical guidance to teams of engineers for systems engineering activities and deliverables
- Assists with development of quality processes consistent with existing practice in collaboration with cross functional stakeholders.
- Other duties as assigned
Responsibilities
- Bachelor’s degree in Software Engineering, Computer Engineering, Computer Science, Biomedical Engineering, Electrical Engineering, Systems Engineering, or equivalent degree/major required. Years of experience may be substituted for the degree requirement.
- Bachelor’s degree with 5 years, or Master’s degree with 3 years experience with development or verification in the medical device industry (Class III medical device experience preferred).
Qualifications
- Experience with development in a regulated industry such as medical device, defense, or automotive.
- Experience in Systems Engineering as related to stakeholder needs definition, creation of use case workflows, requirements definition and decomposition, functional architecture, and system design.
- Experience generating technical documentation such as product requirements, specifications, engineering reports, test plans & procedures, validation plans and reports.
- Experience working on multiple projects in a deadline driven environment.
- Experience with RF communications systems is desirable.
- Ability to generate buy-in from stakeholders to solutions for both technical and non-technical issues.
- Ability and willingness to make sound decisions potentially with high impact in a timely manner.
- Ability to provide creativity while solving complex problems without known solutions.
- Outstanding communication and presentation skills (written and verbal) to all levels of an organization.
- Experience interfacing with Software Development, Mechanical, Electrical, Operations, Quality and Regulatory
- Usability engineering (human factors) experience strongly desired.
- Risk management experience strongly desired.
- Cybersecurity in medical devices experience strongly desired.
- Project management skills including planning and estimation of tasks, milestones, resources, and budget desired.
- Willing to travel up to 10% as needed
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, disability, age or other characteristics protected by laws.
PI240040188
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