Senior R&D Engineer, Advanced Development - Pleasanton, CA

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 Advanced Development team is responsible for early stage development and risk retirement of high risk and high reward design concepts. This team will develop proven ideas that work into the product development pipeline. In This Role, You Will: Invent and evaluate early stage concepts. You will be asked to push limits and come up with creative and ground breaking solutions Lead the design, development, and testing of of critical electromechanical and fluidics systems and subsystems for an innovative kidney stone treatment device. Drive early phase product design concept ensuring manufacturability, reliability, scalability, and cost-effectiveness. Collaborate with cross-functional teams (R&D, Quality, Manufacturing, Regulatory, Clinical, and Marketing) to create solutions that best meets user needs. Develop test methods, create specifications, and execute early phase feasibility testing, including writing reports and documentation. Ensure compliance with FDA regulatory standards, maintaining adherence to the design control process throughout the product development lifecycle. 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. Collaborate with suppliers and internal teams to ensure pr