Hiring: Staff R&D Engineer, Instruments - Pleasanton, CA Company: Calyxo, Inc. Location: Pleasanton, CA Job Posted Time: 2026-09-03 14:33:51 Employment Type: Full-time Target Skills & Keywords : Root Cause Analysis, SolidWorks About the job Experience: •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. •10 years of medical device experience, OR Advanced degree in a related field and a minimum of 9 years of medical device experience. Required Skills: •Lead and oversee developing and ultimately driving Calyxo’s instruments and accessories through to launch. •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. •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 •Who You Will Report To Director, Instruments Engineering Qualifications: •Understanding of medical device regulations, including ISO 13485 and FDA 21 CFR Part 820. •Demonstrated success in 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. Compensation: •$175,000 - $190,000 / year •Employee benefits package that includes 401(k), healthcare insurance and paid vacation Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!