Principal Hardware 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: Weareseekinga highly skilled and innovative hardware engineer to lead development of advanced fluidic subsystems in kidney stone treatment. This role focuses on the design and control of irrigation and aspiration systems, combining pumps, valves, sensors, tubing sets, and embedded software into safe and reliable products. This is ahands‑‑ontechnical leadership role for an engineer who enjoys developing both hardware and control algorithms, working across mechanical, electrical, and software boundaries to deliver clinically robust performance. This role requires ensuring that all engineering effortscomply withindustry standards and regulatory requirements, while aligning with strategic businessobjectives. In This Role, You Will: Own andarchitectend-to-end fluid control systems across capitalequipment and disposable instruments/tubing sets. Define and drive development of control algorithms to regulate irrigation and aspiration under varying clinical and patient conditions. Define system/sub-system performance requirements for flow, pressure, responsiveness, alarms, and fault detection. Perform system modeling, trade studies,prototypingand bench testing to educate keycomponentselection (pumps, sensors, actuators),validatedecisions and de-risk technical challenges. Individually contribute to mechanical/electromechanical design for criticalfluidicssubsystem components and assemblies and provide expert designreviewof other team-members designs. Lead cross-functional alignment across internal teams and external partners to ensure architectural integrity, V & V readiness, and production scalability. Collaborate with Systems & Test Engineering to drive design verification test planning and execution for fluid control hardware subsystems. Lead hardware subsystem risk management activities (e.g., FMEA). Organize system/sub-system-level technical design reviews to ensure coherent design across hardware,firmwareand software interfaces. Collaborate with suppliers and internal operations representatives to perform root cause investigation,componentlifecyclemanagementand continuous improvement. Provide deep subject matterexpertisetoward the technology roadmap for fluidics and controls and related research endeavors. Partner closely with mechanical, electrical, software, systems, clinical, quality, regulatory and other cross-functional teams to bring prototypes to the market. Mentor junior and non-specialist engineering talent, promoting a collaborative and high-performance work environment. Who You Will Report To: Director, Vision and Sensor Systems Requirements: Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Mechatronics, ora relateddiscipline. Master’s or PhD ina relevantengineering discipline preferred. 15+ years of experience developing fluidic, mechatronic, or control systems in a regulated product environment. Experience with owning end-to-end hardware system architectures for fluidic control systems. Preferred familiarity with disposable fluidic component design and reusable/disposable system interfaces. Proven experience developing and tuningclosed‑‑loopcontrol systems for electromechanical hardware. Preferred experience with irrigation and aspiration systems, endoscopic or urological devices, or surgical fluid management platforms. Experience with pressure, flow,air‑‑in‑line, or occlusion detection preferred. Experience prototyping and testing systems at the bench and subsystem level, includingproficiencywith prototype embedded software development (e.g., C/C++, Python, or similar) to support hardware designs. Strong first-principles thinker with expert-level fundamentals in fluid dynamics applied to precision fluid delivery in complex devices. Ability to design experiments, analyze data, and translate results into design improvements. Clear technical communication skills and ability to influence across multidisciplinary teams. Experience leading external vendors and contract development firms. Exceptional structured problem-solving skills and experience leading multifunctional technical project teams through all development lifecycle phases. Prior work on medical devices or othersafety‑‑criticalproducts, including knowledge of IEC 60601, ISO 13485, and medical device design controls. Experience in requirements definition, design reviews, design verification, change management and risk control Ability to travel domestically and internationally up to 10% of the time. What We Offer: 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. A competitive base salary of $210,000 - $230,000 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 deeply committed to fostering an environment where diversity and inclusion are not only valued but also prioritized. 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. We appreciate your interest in joining Calyxo and look forward to getting to know you through our official channels. #J-18808-Ljbffr Calyxo