Sr. Mechanical Engineer - Pleasanton, CA - Calyxo
Pleasanton, CA
About the Job
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.
In This Role, You Will:
- Lead the mechanical design, development, and testing of innovative medical devices for kidney stone treatment.
- Drive the product design efforts from concept to commercialization, ensuring manufacturability, reliability, scalability, and cost-effectiveness.
- Collaborate with cross-functional teams (R&D, Quality, Manufacturing, Regulatory, Clinical, and Marketing) to translate customer and project requirements into detailed engineering designs.
- Develop and validate test methods, create specifications, and execute design verification protocols, including writing reports and documentation.
- Ensure compliance with FDA regulatory standards, maintaining adherence to the design control process throughout the product development lifecycle.
- Manage external testing activities such as sterilization, packaging, and biocompatibility testing, ensuring alignment with project goals and timelines.
- Use SolidWorks to perform engineering calculations, create detailed models, and optimize product designs for manufacturing.
- Communicate project status, risks, and milestones effectively across all relevant departments.
- Support manufacturing by collaborating with suppliers and internal teams to ensure product quality and seamless production.
Who You Will Report To:
- Vice President of Research and Development
Requirements:
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field; advanced degrees preferred.
- Minimum of 6 years of experience in medical device design and development, with expertise in R&D processes.
- Understanding of medical device regulations, including ISO 13485, FDA 21 CFR Part 820 (for design controls and quality management), as well as best practices for mechanical design validation and risk management.
- Proficiency in SolidWorks and a strong understanding of design for manufacturability, tolerance analysis, and cost optimization.
- Strong collaboration and communication skills, with the ability to work effectively on cross-functional teams.
- Experience in product development within regulated industries and knowledge of sterilization and biocompatibility testing.
- Strong problem-solving and analytical skills, with a hands-on approach to product development and testing
- Work location: Pleasanton, CA
- Travel: less than 10%
- Full time employment
- Compliance with relevant county, state, and Federal rules regarding vaccinations.
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.
