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. 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.
In This Role You Will
The Instruments Engineering team is a highly energetic and actively growing team responsible for developing and driving Calyxo’s instruments and accessories through to launch. 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, partnering with cross-functional teams in Manufacturing, Quality, Marketing, Clinical, and Regulatory to bring concepts through all phases of development to commercialization.
- Create prototypes, design fixturing, 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, enabling manufacturability, reliability, and scalability.
- Use SolidWorks to create well-defined models, assemblies, and engineering drawings.
- Solve engineering problems through root cause analysis and data-driven solution finding.
- Define qualification strategies for new designs or processes with cross-functional alignment.
- Translate customer requirements into product requirements and engineering specifications.
- Drive communication with suppliers to progress activities related to component or subassembly development.
- Communicate project progress, results, and risks to 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 to align with project goals and timelines.
Qualifications
- 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 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 through maturation
- Design capabilities in injection molding and in areas such as electro-mechanical sub-systems, catheter construction, endoscope construction, or fluidics
- Experience creating and running simulations (CFD, FEA)
- Experience conducting structured design of experiments (DOEs) and using statistical analysis
- Strong collaboration and communication skills for cross-functional work
- Hands-on problem-solving and analytical skills in 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 vaccination requirements
What We Offer
At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team. You will work in a diverse environment with proven leaders and have opportunities to shape our company culture. You will experience continuous learning and dynamic challenges to help you grow.
Compensation and Perks
- Competitive base salary range of $135,000 - $165,000 and a variable incentive plan
- Stock options – ownership and a stake in growing a mission-driven company
- Employee benefits package including 401(k), healthcare insurance, and paid time off
Calyxo is an equal opportunity employer. We value diversity and inclusion and ensure all applicants receive consideration without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other legally protected characteristics. Legal authorization to work in the United States is required.
Disclaimer
Our interview process is structured to ensure the best fit for candidates and our team. If you suspect a scam, be aware that Calyxo will never request sensitive personal information via email or online forms before an official interview. Our domain format is ; contact to verify legitimacy.
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