Staff Systems Engineer - Pleasanton, CA
$195,000–$205,000 year
On-sitePleasanton, California, United States
Job Summary
Architect, validate, and own the system-level behavior of a complex medical device ecosystem throughout the entire product development lifecycle. Define end-to-end system architecture, translate user needs into robust requirements, and drive architectural trade studies using bench testing and prototyping to de-risk critical technical challenges. Lead identification and mitigation of system-level risks, ensure complete traceability from user needs through verification, and serve as the systems subject-matter expert across mechanical, electrical, firmware, software, clinical, and quality teams. Provide clear technical direction to external development partners and mentor engineers on systems thinking and architectural rigor.
Required Qualifications
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related field
- 12+ years of experience in medical device development
- significant ownership of system architecture
- Strong hands-on experience with both: Single-use disposable systems, Capital equipment incorporating pumps, sensors, and closed-loop control
- Experience architecting systems that integrate hardware, disposables, and software
- Proven ownership of system-level requirements and verification
- Proficiency with Jama (or equivalent), dFMEAs, fault-tree analysis, and requirements traceability
- Strong working knowledge of relevant medical device standards (e.g., ISO 14971, IEC 62304, IEC 60601 family)
- Track record of writing high-quality, testable requirements that scale across complex systems
- Staff-level technical judgment and decision-making capability
- Ability to lead through influence and technical authority rather than direct reporting lines
- Clear, concise technical communicator across disciplines and experience levels
- Comfortable operating in ambiguity, making informed trade-offs, and driving alignment
- Location: Pleasanton, CA (on-site presence expected 4–5 days per week)
- Travel: Minimal (<10%)
- Legal authorization to work in the United States
Desired Qualifications
- Master's or PhD
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