Overview
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 group responsible for developing and driving Calyxo\'s instruments and accessories through to launch. In this role, you will lead the design and development of new solutions 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 work with cross-functional partners in Manufacturing, Quality, Marketing, Clinical, and Regulatory to drive concepts through all phases of development to commercialization.
In This Role You Will
- Lead the design and development of new single-use devices and accessories, serving as a technical lead for the team and a core team lead for R&D and cross-functional project teams.
- 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, partnering with other teams across the organization to gain alignment.
- 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 IP portfolio.
- 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 related to component or subassembly development.
- 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 with a minimum of 10 years of medical device experience, OR advanced degree with a minimum of 9 years of medical device experience.
- 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 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.
- Proven design capabilities in two or more of the following: injection molding, electromechanical sub-systems, catheter construction, endoscope construction, fluidics.
- Experience creating and running simulations (CFD, FEA) to inform product development.
- Proficiency in conducting structured design of experiments (DOEs) and using statistical methods to analyze data.
- Proven track record of taking new designs from concept stage through commercialization.
- 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
- Competitive base salary range of $160,000 - $180,000 plus a 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 time off
Commitment to Diversity & Equal Opportunity
Calyxo is deeply committed to fostering an environment where individuals are valued and 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. All applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, 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 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 note:
- Structured Interview Process : Our hiring process includes multiple stages of interviews where you will have the opportunity to communicate directly with Calyxo employees, ensuring you gain a comprehensive understanding of the role and our company culture.
- Verification : We do not extend job offers without first meeting candidates, either virtually or in person.
- Beware of Scams : Calyxo will never request sensitive personal information via email or online forms before an official interview. Please verify communications come from an official Calyxo domain and contact info at if you have any concerns.
We appreciate your interest in joining Calyxo and look forward to connecting through our official channels.
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