Principal Hardware Engineer - Fluidics - Pleasanton, CA

Calyxo; Pleasanton (CA); On-site; USD 250,000 - 270,000; Full time

Benefits offered by this job

Stock options

401(k) plan

Healthcare

Paid vacation

Job summary

Calyxo, Inc. is a medical device company in Pleasanton, California, seeking a highly skilled hardware engineer to lead development of advanced fluidic subsystems for kidney stone treatment.

You will design and control irrigation and aspiration systems, integrating pumps, valves, sensors, tubing, and embedded software into safe, reliable products. You will partner with mechanical, electrical, software, systems, regulatory, and quality teams to ensure V&V readiness, design reviews, and production

Qualifications

• 15+ years in fluidic, mechatronic, or control systems within regulated environments.
• End-to-end hardware system architectures for fluidic control.
• Experience with irrigation/aspiration systems or surgical fluid management devices.
• Prototype embedded software development (C/C++, Python).
• Strong fundamentals in fluid dynamics for precision delivery.
• Ability to travel up to 10% domestically and internationally.
• Experience with IEC 60601, ISO 13485 and medical device design controls.

Responsibilities

• Own and architect end-to-end fluid control systems for capital equipment and disposables.
• Develop control algorithms for irrigation and aspiration under clinical conditions.
• Define system performance requirements for flow, pressure, alarms, and fault detection.
• Model, prototype, and bench test to inform component selection and de-risk challenges.
• Contribute to mechanical/electromechanical design and review peer designs.
• Lead cross-functional alignment to ensure architectural integrity and production scalability.
• Collaborate with Systems & Test Engineering for design verification planning.
• Lead hardware subsystem risk management activities (e.g., FMEA).
• Organize design reviews across hardware, firmware, and software interfaces.
• Coordinate with suppliers and internal teams on root cause analysis and lifecycle management.
• Provide subject matter expertise toward the fluidics and controls technology roadmap.
• Partner with multidisciplinary teams to move prototypes to market.
• Mentor junior engineers and promote a high-performance culture.

Skills

Fluidic control systems

Mechatronics

Control systems

Embedded software

System architecture

Education

Bachelor's degree in Mechanical/Biomedical/Electrical

Master's or PhD preferred

Job description

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 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 fluidic 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 subsystem 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 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.

WhatWeOffer:

AtCalyxo, 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 offeran attractivecompensation package, which includes:

• A competitive base salary of $250,000 - $270,000 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.