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: Calyxois seeking aStaffSystems Engineertoarchitect,validate,andown the system-level behavior of a complex medical device ecosystem throughoutthe entire product development lifecycle. You will defineandown theend-to-end system architecture, translate userandbusiness needs into robust systemandsubsystem requirements,validatearchitectural decisions through prototypingandbench testing,andproactivelyderiskcritical technical challenges. This role carriesdirect accountability for system-levelrequirementsownershipandverification. The ideal candidate combineshands-onmedical device experience, strongsystems thinking,andthe technical leadership expected of astaff-level engineeroperatingacross hardware, software, disposables,andclinical use environments. In This Role, You Will: System Architecture:
- Architect systems with a strong focus on technicalandpatient risk mitigation.
- Establishandcontrol system interfaces, including fluidic, mechanical, electrical,andsoftware-control boundaries.
- Drive architectural trade studies using bench testing, prototyping,andsimulation tovalidatedesign decisions.
- Ensure architectural robustness across intended use, misuse, fault conditions,andedge cases.
Requirements Ownership & Decomposition:
- Own creation, maintenance,andverification of system-level requirements, with particular emphasis on performance, safety,andreliability.
- Decompose user, clinical,andbusiness needs into clear, testable systemandsubsystem requirements.
- Ensure complete traceability from user needs through requirements, risks, mitigation,andverification.
- Write requirements that are technically precise, non-prescriptive,and verification-ready.
Risk Reduction & Technical Validation:
- Lead identificationandmitigation of system-level risks.
- Own or significantly contribute to system-leveldFMEAs, ensuring strong linkage between requirements, risk controls,andverification activities.
- Defineandsupport system-level verification strategies, ensuring requirements are objectively testableandclinically relevant.
- Actively de-risk novel or critical aspects of the system through early experimentationandfocused learning cycles.
Cross-Functional Technical Leadership:
- Serve as the systemssubject-matterexpert across mechanical, electrical, firmware, software, clinical, quality,andproduct teams.
- Lead architecture reviews, requirements reviews,andsystem-level design discussions.
- Work closely with other technical leads (mechanical, electrical,andSW) to ensure a fully functional system.
- Provide clear technical directionand interfacecontrol to external development partners, ensuring alignment withCalyxo'ssystem architectureandverification strategy.
- Mentor engineers on systems thinking, requirement quality,andarchitectural 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'sorPhD stronglypreferred.
- 12+ years of experience in medical device development, withsignificant ownership of system architecture.
- Stronghands-on experience with both:
- Single-use disposable systems.
- Capital equipmentincorporating pumps, sensors,andclosed-loop control.
Technical Expertise:
- Experience architecting systems that integratehardware, disposables,andsoftware.
- Proven ownership ofsystem-level requirementsandverification.
- Proficiencywith Jama (or equivalent),dFMEAs, fault-tree analysis,and requirementstraceability.
- Strong working knowledge of relevant medical device standards (e.g., ISO 14971, IEC 62304, IEC 60601 family).
- Track recordof writing high-quality, testable requirements that scale across complex systems.
Leadership & Communication:
- Staff-level technical judgmentanddecision-making capability.
- Ability to lead through influenceandtechnical authority rather than direct reporting lines.
- Clear, concise technicalcommunicatoracross disciplinesandexperience levels.
- Comfortable operating in ambiguity, making informed trade-offs,anddriving alignment.
Work Conditions:
- Location: Pleasanton, CA (on-site presence expected 4-5 days per week).
WhatWeOffer: AtCalyxo, you will be part of a knowledgeable, high-achieving,experienced andfun team.You will work in a diverse work environment with experienced, proven leadersandhave an opportunity to shape our company culture.You will experience constant learninganddynamic challenges to help you growandbe the best version of yourself. We also offeran attractivecompensation package, which includes:
- A competitive base salary range of $195,000 - $205,000 andvariable incentive plan.
- Stock options - ownershipanda stake in growing a mission-driven company.
- Employee benefits package that includes 401(k), healthcare insuranceandpaid vacation.
Calyxo is deeply committed to fostering an environment where diversity and inclusion are not onlyvalued but alsoprioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities, which strengthen our focus and fuel our growth. Calyxo is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify their identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. Disclaimer: At Calyxo, we prioritize a transparent and structured interview process to ensure the best fit for both our candidates and our team. Please be aware of the following:
- Structured Interview Process: Our hiring process includes multiple stages of interviews where you will have the opportunity to communicate directly with Calyxo employees. This ensures that you gain a comprehensive understanding of the role and our company culture.
- Verification of Identity: We do not extend job offers without first meeting candidates, either virtually or in person. This step is crucial to maintain the integrity of our hiring process and to ensure mutual alignment.
- Beware of Scams: Calyxo will never request sensitive personal information, such as your full name, address, phone number, or identification documents, via email or online forms before an official interview. Calyxo representatives will always contact you using an email format offirstname.lastname@calyxoinc.com. If you receive a request for information from any other domain, please contact us directly at info@calyxoinc.com to verify the legitimacy of the communication.
We appreciate your interest in joining Calyxo and look forward to getting to know you through our official channels. |
Calyxo, Inc.
$195,000 - $205,000
401(k), stock options
Aug 17, 2026