Job Title: Systems Integration Engineer III
Client Location: Bay Area, CA
Employment Category: Direct Hire
Max Base Salary Offering: $180,000.00
Benefits Offered: Medical - Dental - Vision - Retirement Savings - ESPP - Company Bonuses
Citizenship Requirement: Open Requirement
Onboarding Requirement: Background & Drug-Screen
Projected Start Date: ASAP
The Systems Integration Engineer will play a key role in the development of a Class III implantable Neuromodulation system for pain management, working cross-functionally to help verify firmware, software applications, and whole systems and make sure that all stakeholders are aligned, and requirements and user needs are met.
Essential Duties and Responsibilities:
- Designs develop, updates, executes, and debugs firmware and system tests (manual, interactive, automated) and maintain testing metrics.
- Conducts and participates in cross-functional reviews of the test protocol development (test strategy, test design, test code).
- Owns technical documentation such as engineering reports, verification plans, procedures and reports, and validation plans and reports.
- Performs and analyzes system setup and conducts verification and validation activities.
- Performs hands-on system integration testing and troubleshooting of technical issues, working with developers to identify the root cause and viable resolutions, document issues found, and verify bug fixes of software defects.
Minimum Qualifications: (Knowledge, Skills, and Abilities)
- Bachelor's degree in Electrical Engineering, Computer Engineering, Biomedical Engineering, Systems Engineering, or equivalent degree/major required. Years of experience may be substituted for the degree requirement.
- 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 scripting with high-level programming languages such as Python or PHP.
- Proficient with C# [.NET] or other equivalent development tools for creating automated tests.
- Hands-on experience with oscilloscopes, power supplies, and other standard lab equipment.
- 2-5+ years' experience with development or verification in the medical device industry. (class III medical device experience preferred)
- Working knowledge of IEC 60601, ISO 14708, IEC 62304
- Experience with RF communications systems and active implantable systems
- Knowledge of C and an understanding of embedded firmware
- Risk management (risk analysis, FMEA, ISO 14971) experience
- Good communication skills (Written/Orally) are required. Outstanding communication and presentation skills (written and verbal).
- Strong track record of working in cross-functional teams.
- Ability to work on multiple projects in a deadline-driven environment.
- Ability to provide creativity while solving complex problems without known solutions.