Principal Hardware Engineer - Pleasanton, CA

Summary:  

We are seeking a 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 a hands‑on technical 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 efforts comply with industry standards and regulatory requirements, while aligning with strategic business objectives. 

In This Role, You Will: 

• Own and architect end-to-end fluid control systems across capital equipment 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, prototyping and bench testing to educate key component selection (pumps, sensors, actuators), validate decisions and de-risk technical challenges. 

• Individually contribute to mechanical/electromechanical design for critical fluidics subsystem components and assemblies and provide expert design review of 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 sub-system risk management activities (e.g., FMEA). 

• Organize system/sub-system-level technical design reviews to ensure coherent design across hardware, firmware and software interfaces.  

• Collaborate with suppliers and internal operations representatives to perform root cause investigation, component lifecycle management and continuous improvement.  

• Provide deep subject matter expertise toward 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, or a related discipline. Master’s or PhD in a relevant engineering 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 tuning closed‑loop control 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, including proficiency with 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 other safety‑critical products, 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.   

We also offer an attractive compensation package, which includes: 

• 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