Senior R&D Engineer, Instruments

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 for developing and ultimately driving Calyxo's instruments and accessories through to launch. In this role, you will drive the design and development of new solutions for both released and next-generation critical components and accessories, integrating these solutions alongside the vision, sensors, and software R&D teams, 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 bring these novel concepts through all phases of development to commercialization.

In this Role You Will:

• Create prototypes, design fixturing, devise feasibility studies, and execute testing to draw meaningful conclusions and guide product development.
• Ensure design and development pathways maintain adherence to the design control process, working with cross-functional partners to enable manufacturability, reliability, and scalability.
• Use SolidWorks to create well-defined models, assemblies, and engineering drawings.
• Effectively solve engineering problems through methodical root cause analysis and data-driven solution finding.
• Define qualification strategies for new designs or processes, working in partnership with other teams across the organization to gain alignment.
• Meaningfully translate customer requirements into new or revised product requirements and engineering specifications.
• Drive communication with suppliers to progress activities relevant to component or subassembly development.
• Effectively communicate project progress, results, and risks to relevant stakeholders.
• Develop and validate verification test methods, create and execute protocols, and author associated reports and risk documentation.
• Coordinate external testing activities such as sterilization, packaging, and biocompatibility testing, ensuring alignment with project goals and timelines.

Requirements:

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field, and a minimum of 5 years of medical device experience, OR
• Advanced degree in a related field and a minimum of 4 years of medical device experience
• Understanding of medical device regulations, including ISO 13485 and FDA 21 CFR Part 820.
• Ability to apply DFX principles to create designs that can scale.
• Proficiency in SolidWorks and a strong understanding of design for manufacturability, tolerance stack analysis, and GD&T.
• Track record of taking design concepts from prototyping stage through to design maturation.
• Proven design capabilities in two or more of the following key areas: injection molding, electro-mechanical sub-systems, catheter construction, endoscope construction, fluidics.
• Experience creating and running simulations (CFD, FEA) to inform product development.
• Solid experience 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 in product development within regulated industries and knowledge of sterilization and biocompatibility testing.
• Work location: Pleasanton, CA
• Travel: less than 10%
• Full time employment
• Compliance with relevant county, state, and Federal rules regarding vaccinations.

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 a compensation plan as follows:

• Competitive base salary range of $135,000 - $165,000
• Stock options - ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid time off

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.