Staff R&D Engineer, Instruments - Pleasanton, CA

Calyxo; Pleasanton (CA); On-site; USD 175,000 - 190,000; Full time

Benefits offered by this job

Stock options

401(k)

Healthcare insurance

Paid vacation

Job summary

Calyxo, Inc. in Pleasanton, CA, is seeking an experienced engineer to lead the design and development of single-use kidney-stone treatment devices.

You will guide cross-functional teams from concept through commercialization, using SolidWorks for modeling and applying DFx to scalable designs. You will mentor engineers, drive design controls, and collaborate with Manufacturing, Quality, Marketing, Clinical, and Regulatory to push innovative concepts to launch.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field with 10+ years medical device experience, OR advanced degree with 9+ years.
• Work location: Pleasanton, CA.
• Travel: less than 10%.
• Full-time employment.
• Understanding of ISO 13485 and FDA 21 CFR Part 820.
• Experience leading technical teams and mentorship.
• Proven track record from concept to commercialization.
• DFX for manufacturability.
• Design in two or more areas: injection molding, electromechanical subsystems, catheter construction, endoscope construction, fluidics.
• SolidWorks proficiency; DFM, tolerance stack analysis, and GD&T.
• DOE with statistical analysis.
• Strong collaboration and hands-on testing.
• Experience CFD/FEA simulations.
• Experience in regulated industries and sterilization/biocompatibility testing.
• Vaccination compliance.

Responsibilities

• Lead design and development activities of new single-use devices and accessories as technical lead.
• Ensure design controls, manufacturability, reliability, and scalability with cross-functional partners.
• Create prototypes, fixtures, feasibility studies, and testing to guide product development.
• Solve engineering problems with root cause analysis and data-driven solutions.
• Define and lead qualification strategies for new designs or processes.
• Translate customer requirements into engineering specifications.
• Use SolidWorks to create models, assemblies, and drawings.
• Generate IP and contribute to the IP portfolio.
• Communicate progress, results, and risks to stakeholders.
• Develop test methods, protocols, and risk documentation.
• Coordinate with suppliers for component or subassembly development.
• Coordinate external testing such as sterilization and biocompatibility.

Skills

Leadership

Cross-functional collaboration

Mentorship

Design for manufacturability

GD&T

Root cause analysis

DOE / statistics

Problem solving

Team communication

Education

Bachelors in Mechanical/Biomedical Eng

Advanced degree (MS/PhD)

Tools

SolidWorks

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:

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 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 maintain adherence 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 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.
• 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 associated reports and risk documentation.
• Drive communication with suppliers to progress activities relevant to component or subassembly development.
• Coordinate external 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 10 years of medical device experience, OR
• Advanced degree in a related field and a minimum of 9 years of medical device experience.
• Work location: Pleasanton, CA
• Travel: less than 10%
• Full time employment
• 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 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 an attractive compensation package, which includes:

• A competitive base salary range of $175,000 - $190,000 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.

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.

We appreciate your interest in joining Calyxo and look forward to getting to know you through our official channels.