Staff Systems Engineer - Pleasanton, CA

Summary Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, focused on kidney stone treatment. We are looking for 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. Responsibilities System Architecture Architect systems with a focus on technical and patient risk mitigation. Establish and control system interfaces across 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, emphasizing 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. Define and support verification strategies, ensuring requirements are objectively testable and clinically relevant. Actively de‑risk novel or critical aspects 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 to ensure a fully functional system. Provide clear technical direction and interface control to external development partners. Mentor engineers on systems thinking, requirement quality, and architectural rigor. Reporting Systems and Test Senior Manager Requirements Education & Experience Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field; Master’s or PhD strongly preferred. 12+ years of experience in medical device development, with significant ownership of system architecture. Hands‑on experience with both single‑use disposable systems and capital equipment incorporating pumps, sensors, and closed‑loop control. Technical Expertise 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 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. Leadership & Communication Staff‑level technical judgment and decision‑making capability. Ability to lead through influence and technical authority. Clear, concise technical communicator across disciplines and experience levels. Comfortable operating in ambiguity, making informed trade‑offs, and driving alignment. Work Conditions Location: Pleasanton, CA (on‑site presence expected 4-5 days per week). Travel: Minimal ( What We Offer Competitive base salary range of $195,000–$205,000 and variable incentive plan. Stock options – ownership and a stake in a growing mission‑driven company. Employee benefits package including 401(k), healthcare insurance, and paid vacation. Equal Opportunity Employment Calyxo is proudly an equal opportunity employer and welcomes applicants without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other legally protected characteristics. Legal authorization to work in the United States is required. All persons hired will be required to verify their identity and eligibility to work in the United States and complete the required employment eligibility verification form upon hire. #J-18808-Ljbffr Calyxo, Inc.