Principal Hardware Engineer Fluidics 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 ahandsontechnical 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 studiesprototypingand 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.

• Leadhardwaresub-system risk management activities (e.g. FMEA).

• Organize system/sub-system-level technical design reviews to ensure coherent design across hardwarefirmwareand software interfaces.

• Collaborate with suppliers and internal operations representatives to perform root cause investigationcomponentlifecyclemanagementand 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:

• Bachelors degree in Mechanical Engineering Biomedical Engineering Electrical Engineering Mechatronics ora relateddiscipline. Masters 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 fluidiccomponentdesign and reusable/disposable system interfaces.

• Proven experience developing and tuningclosedloopcontrol systems for electromechanical hardware. Preferred experience with irrigation and aspiration systems endoscopic or urological devices or surgical fluid management platforms. Experience with pressure flowairinline 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 othersafetycriticalproducts 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-achievingexperiencedand 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 competitivebasesalary of $250000 - $270000 and variable incentive plan

• Stock options ownership and a stake in growing amission-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 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 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 of. If you receive a request for information from any other domain please contact us directly at 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.