About the job
Calyxo, Inc. is a pioneering medical device company based in Pleasanton, California, established in 2016 to revolutionize kidney stone treatment. We are dedicated to addressing the significant challenges posed by kidney stone disease, a prevalent condition that places substantial strain on healthcare resources. Our leadership team comprises seasoned executives and investors with a remarkable track record in bringing innovative devices to market, specifically tailored to meet the critical needs of the urology sector.
Join us in transforming the landscape of kidney stone treatment! We are looking for high performers eager to be part of a vibrant, diverse team that fosters creativity and collaboration.
Summary:
We are in search of a meticulous and experienced Staff Quality Engineer to become a key member of our New Product Development (NPD) team. This position plays a vital role in guaranteeing that our Class-II medical devices uphold the utmost quality standards throughout their development journey, from initial concept to market launch. The ideal candidate will possess extensive experience within the medical device industry and a robust grasp of quality engineering principles, design controls, project management, and regulatory frameworks.
The focus of this role is to ensure quality is seamlessly integrated into the design, development, and production of our novel medical devices. A solid foundation in quality engineering related to Class-II or Class-III product development and software development, from concept to commercialization, will be essential for success.
In This Role, You Will:
- Oversee design controls for new product development and improvement initiatives, ensuring compliance with Calyxo's Quality System, FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 60601, and pertinent global regulations.
- Lead risk management efforts in accordance with ISO 14971, encompassing risk management planning, hazard analysis, FMEAs (design, software, user), risk-benefit assessments, and comprehensive risk management reporting.
- Maintain and manage design control documentation in alignment with ISO 13485 and 21 CFR Part 820 standards.
- Collaborate with Research & Development, Project Management Office, Regulatory Affairs, and Manufacturing to integrate robust design inputs, outputs, traceability, and quality considerations throughout all stages of product development.
- Ensure accurate and current quality documentation, including test reports, validation records, and risk management documents. Prepare and present quality-related updates to management and project teams.

