Staff Systems Engineer - Pleasanton, CA

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 c and idate combines  h and s -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:     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 .   1 2 + years of experience in medical device development, with  significant ownership of system architecture .   Strong  h and s -on experience with both:   Single-use disposable systems.   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 relevant medical device st and ards (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 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.   Work Conditions:   Location: Pleasanton, CA (on-site presence expected 4–5 days per week).   Travel: Minimal (<10%).   What  W e  O ffer :   At  Calyxo , you will be part of a knowledgeable, high-achieving,  experienced   and  fun team .   You will work in a diverse work environment with experienced, proven leaders  and  have an opportunity to shape our company culture .   You will experience constant learning  and  dynamic challenges to help you grow  and  be the best version of yourself .     We also offer  an attractive  compensation package, which includes :   A competitive base salary range of $195,000 - $205,000 and  variable incentive plan.   Stock options – ownership  and  a stake in growing a mission-driven company.   Employee benefits package that includes 401(k), healthcare insurance  and  paid vacation.   Calyxo is de