Staff Quality Engineer, Design Quality - 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: We are seeking a skilled and detail-oriented Staff Quality Engineer to join our New Product Development (NPD) team. This role is responsible for ensuring that our Class-II new products meet the highest quality standards throughout the development process, from concept to commercialization. The ideal candidate will have experience in the medical device industry and a strong understanding of quality engineering principles, design controls, project management, and regulatory requirements. This role will focus on ensuring that quality is embedded in the design, development, and manufacturing of new medical devices. The ideal candidate will have a strong background in quality engineering within the medical device industry, with experience supporting Class-II or Class-III product development lifecycle and software development, from concept through commercialization. In This Role, You Will : Ensure design controls for new product development and improvement project activities, including risk management, design V&V, product software validation, design reviews, tagging/tracing, non-product tools validation, test method validation, and design transfer are in compliance with Calyxo Quality System, FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 60601, and relevant global regulations. Drive risk management activities per ISO 14971, including risk manag