Staff R&D Engineer, Instruments - 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:   

The Instruments Engineering team is a highly energetic and actively growing team that is responsible fordeveloping and ultimately drivingCalyxo’sinstruments and accessories through to launch. In this role, you will lead design and development activities for released and next-generation devices and accessories, ensuring seamless integration of mechanical systems with vision, sensors, and software, and catalyzing the advancement of an innovative, single-use kidney stone treatment device. You will be immersed in a highly collaborative and multidisciplinary team, teaming up with cross-functional partners in Manufacturing, Quality, Marketing, Clinical, and Regulatory to successfully drive these novel concepts through all phases of development to commercialization.  

In This Role, You Will:  

• Lead design and development activities of new single-use devices and accessories, serving as a technical lead for these activities, and a core team lead, when required. 

• Ensure design and development pathways maintainadherence to the design control process,working with cross-functional partners to enable manufacturability, reliability, and scalability. 

• Create prototypes, design fixturing, devise feasibility studies, and execute testing to draw meaningful conclusions and guide product development.  

• Effectively solve engineering problems through methodical root cause analysis and data-driven solution finding. 

• Define and lead qualification strategies for new designsor processes, working in partnership with other teams across the organization to gain alignment. 

• Meaningfullytranslate customer requirements intonew or revisedproduct requirements and engineering specifications. 

• Use SolidWorks to create well-defined models, assemblies, and engineering drawings. 

• Generate purposeful Intellectual Property (IP)and contribute to the overall IP portfolio. 

• Effectively communicate project progress, results, and risks to relevant stakeholders. 

• Develop test methods,create and execute protocols, and author associatedreports and risk documentation. 

• Drive communication with suppliers to progress activities relevant to componentor subassembly development. 

• Coordinateexternal testing activities such as sterilization, packaging, and biocompatibility testing, ensuring alignment with project goals and timelines. 

Who You Will Report To:  

•  Director, Instruments Engineering

Requirements:  

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field and a minimum of 10years of medical device experience, OR 

• Advanceddegree in a related field and a minimum of 9years of medical device experience. 

• Work location: Pleasanton, CA 

• Travel: less than 10% 

• Full timeemployment 

• Understanding of medical device regulations, including ISO 13485 and FDA 21 CFR Part 820. 

• Experience leading technical teams and providing mentorship to other engineers. 

• Proven track record of taking new designs from concept stage through to commercialization.  

• Proven ability to apply DFX principles to create designs that can scale. 

• Proven design capabilities in two or more of the following key areas: injection molding, electromechanical sub-systems, catheter construction, endoscope construction, fluidics. 

• Proficiency in SolidWorks and a strong understanding of design for manufacturability, tolerance stack analysis, and GD&T.  

• Proficiency in conducting structured design of experiments (DOEs) and using statistical methods to analyze data. 

• Strong collaboration and communication skills, with the ability to work effectively on cross-functional teams. 

• Strong problem-solving and analytical skills, with a hands-on approach to product development and testing. 

• Experience creating and running simulations (CFD, FEA) to inform product development. 

• Experience in product development within regulated industries and knowledge of sterilization and biocompatibility testing. 

• Compliance with relevant county, state, and Federal rules regardingvaccinations. 

What We Offer:  

At Calyxo, you will be part of a knowledgeable, high-achieving, experiencedand 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 attractivecompensation package, which includes: 

• A competitive base salary range of $175,000 - $190,000and 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 only valued but also prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impactpeople 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, seekingto 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 statusor 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 of [email protected]. If you receive a request for information from any other domain, please contact us directly at [email protected]   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.