Staff Systems Engineer - Pleasanton, CA

Experteer Overview In this role, you will architect and own the system-level behavior of Calyxo’s complex medical device ecosystem across the product lifecycle. You’ll define end-to-end system architecture, translate user and business needs into robust requirements, and validate decisions through prototyping and bench testing. You are accountable for system-level requirements ownership and verification, driving risk reduction and cross-functional collaboration. This is a mission-driven opportunity to shape a medical device platform in kidney stone treatment. Compensation / Benefits * Architect systems with strong focus on technical and patient risk mitigation; define interfaces across fluidic, mechanical, electrical and software-control boundaries * Own creation, maintenance and verification of system-level requirements with emphasis on performance, safety and reliability; ensure traceability from user needs to risks and verification * Lead risk reduction and technical validation through dFMEAs, verification strategies, and early experimentation to de-risk critical aspects * Serve as systems SME across mechanical, electrical, firmware, software, clinical, quality, and product teams; lead architecture and requirements reviews; provide direction and interface control to external development partners * Mentor engineers on systems thinking and requirements quality; drive alignment across disciplines Tasks * 12+ years of experience in medical device development with significant ownership of system architecture * Hands-on experience with single-use disposable systems and capital equipment with pumps, sensors, and closed-loop control * Experience architecting systems that integrate hardware, disposables, and software; ownership of system-level requirements and verification * Proficiency with Jama (or equivalent), dFMEAs, fault-tree analysis, and requirements traceability * Strong knowledge of ISO 14971, IEC 62304, IEC 60601 family; track record of writing high-quality, testable requirements across complex systems * Bachelor’s degree in Mechanical Engineering; Master’s or PhD strongly preferred * Staff-level technical judgment and ability to lead through influence (not direct reporting) * Clear, concise technical communicator across disciplines and experience levels Key requirements * Competitive base salary * Variable incentive plan * Stock options * 401(k) * Healthcare insurance * Paid vacation

to dFMEAs, verification strategies, and early experimentation to de-risk critical aspects * Serve as systems SME across mechanical, electrical, firmware, software, clinical, quality, and product teams; lead architecture and requirements reviews; provide direction and interface control to external development partners * Mentor engineers on systems thinking and requirements quality; drive alignment across disciplines Tasks * 12+ years of experience in medical device development with significant ownership of system architecture * Hands-on experience with single-use disposable systems and capital equipment with pumps, sensors, and closed-loop control * Experience architecting systems that integrate hardware, disposables, and software; ownership of system-level requirements and verification * Proficiency with Jama (or equivalent), dFMEAs, fault-tree analysis, and requirements traceability * Strong knowledge of ISO 14971, IEC 62304, IEC 60601 family; track record of writing high-quality, testable a aaaaaaaaay_ across complex systems * Bachelor’s degree in Mechanical Engineering; Master’s or PhD strongly preferred * Staff-level technical judgment and ability to lead through influence (not direct reporting) * Clear, concise technical communicator across disciplines and experience levels Key requirements * Competitive base salary * Variable incentive plan * Stock options * 401(k) * Healthcare insurance * Paid vacation