Staff R&D Engineer, Instruments - Pleasanton, CA

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

Benefits offered by this job

Stock options

Healthcare insurance

401(k) plan

Paid vacation

Job summary

Calyxo, Inc. in Pleasanton, CA is developing a single-use kidney stone treatment device.

The Instruments Engineering team leads design and development from concept through launch, integrating mechanical systems with vision, sensors, and software to advance novel concepts to commercialization. You will collaborate with Manufacturing, Quality, Marketing, Clinical, and Regulatory to translate customer requirements into engineering specifications; use SolidWorks for models and drawings; contribute

Qualifications

• Bachelor’s degree in Mechanical or Biomedical Engineering; 10+ years medical device experience.
• Advanced degree in related field; 9+ years medical device experience.
• Work location: Pleasanton, CA.
• Travel: less than 10%.
• Full-time employment.
• Knowledge of ISO 13485 and FDA 21 CFR Part 820.
• Experience leading technical teams and mentoring engineers.
• Proven track record from concept to commercialization.
• Ability to apply DFX principles to scalable designs.
• Experience in injection molding, electromechanical subsystems, catheter construction, or endoscope construction, or fluidics.
• SolidWorks proficiency; tolerancing and GD&T.
• DOE and statistical data analysis experience.
• Strong collaboration and communication skills.
• Hands-on product development and testing.
• Simulation experience (CFD, FEA) to inform design.
• Experience in regulated industries; knowledge of sterilization and biocompatibility testing.
• Vaccination compliance with county, state, and federal rules.
• Legal authorization to work in the United States.

Responsibilities

• Lead design and development activities of new single-use devices and accessories, as technical lead and core team lead.
• Ensure design and development pathways adhere to design control, enabling manufacturability and reliability.
• 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.
• Drive supplier communication for component development.
• Coordinate external testing such as sterilization, packaging, and biocompatibility.

Skills

Leadership

Cross-functional collaboration

Problem-solving

DOE

CFD/FEA simulations

Statistical analysis

Regulatory knowledge

Education

Bachelor’s degree in Mechanical Engineering

Bachelor’s degree in Biomedical Engineering

Advanced degree in related field

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 t ranslate customer r equirements 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 c ommunicate project progress , results, and risks to relevant stakeholders.
• Develop test methods, create and execute protocols, and author associated r eports 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.
• 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.

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 .

• A c ompetitive 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.