Staff Systems Engineer - Pleasanton, CA

Job description

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology. Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere. **Summary:** Calyxo is seeking a **Staff Systems Engineer**to architect, validate, and own the system-level behavior of a complex medical device ecosystem throughout the entire product development lifecycle. You will define and own the **end-to-end system architecture**, translate user and business needs into robust system and subsystem requirements, validate architectural decisions through prototyping and bench testing, and proactively de‑risk critical technical challenges. This role carries **direct accountability for system-level requirements ownership and verification**. The ideal candidate combines **hands-on medical device experience**, strong **systems thinking**, and the technical leadership expected of a staff-level engineer operating across hardware, software, disposables, and clinical use environments. **In This Role, You Will:** **System Architecture:** - Architect systems with a strong focus on technical and patient risk mitigation. - Establish and control system interfaces, including fluidic, mechanical, electrical, and software-control boundaries. - Drive architectural trade studies using bench testing, prototyping, and simulation to validate design decisions. - Ensure architectural robustness across intended use, misuse, fault conditions, and edge cases. **Requirements Ownership & Decomposition:** - Own creation, maintenance, and verification of system-level requirements, with particular emphasis on performance, safety, and reliability. - Decompose user, clinical, and business needs into clear, testable system and subsystem requirements. - Ensure complete traceability from user needs through requirements, risks, mitigation, and verification. - Write requirements that are technically precise, non-prescriptive, and verification-ready. **Risk Reduction & Technical Validation:** - Lead identification and mitigation of system-level risks. - Own or significantly contribute to system-level dFMEAs, ensuring strong linkage between requirements, risk controls, and verification activities. - Define and support system-level verification strategies, ensuring requirements are objectively testable and clinically relevant. - Actively de-risk novel or critical aspects of the system through early experimentation and focused learning cycles. **Cross-Functional Technical Leadership:** - Serve as the systems subject-matter expert across mechanical, electrical, firmware, software, clinical, quality, and product teams. - Lead architecture reviews, requirements reviews, and system-level design discussions. - Work closely with other technical leads (mechanical, electrical, and SW) to ensure a fully functional system. - Provide clear technical direction and interface control to external development partners, ensuring alignment with Calyxo’s system architecture and verification strategy. - Mentor engineers on systems thinking, requirement quality, and architectural rigor. **Who You Will Report To:** - Sr. Manager, Systems and Test Engineering **Requirements:** **Education & Experience:** - Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field; **Master’s or PhD strongly preferred**. - 1