About the job
Calyxo, Inc., based in Pleasanton, CA, develops medical devices for kidney stone disease. Founded in 2016, the company’s leadership brings experience in launching new urology products. Calyxo’s mission centers on addressing important needs in kidney stone treatment through innovative device solutions.
Role overview
The Manufacturing Engineer – Capital will focus on developing, improving, and maintaining manufacturing processes for the CVAC 2.0 product line. This position works closely with R&D, Quality, and Manufacturing teams to ensure that processes meet high standards for quality, efficiency, and scalability. The role includes supporting production, driving process improvements, and helping to transition new products and processes into manufacturing. Regulatory compliance and product quality are essential responsibilities.
Main responsibilities
- Lead technical projects to create or enhance manufacturing processes for the CVAC 2.0 product line.
- Collaborate with R&D, Quality, Manufacturing Technicians, and other departments to design and implement processes that improve performance, lower costs, and strengthen quality and safety.
- Assist in developing manufacturing procedures, tooling, and fixtures to meet customer demand and uphold product standards.
- Support production lines by troubleshooting, making process improvements, and assisting operators as needed.
- Train and mentor production staff during the rollout of new products and processes.
- Create and maintain manufacturing documentation in line with company policies and procedures.
- Use LEAN, Six Sigma, and other recognized methods to support problem-solving and continuous improvement.
- Identify equipment needs for production and evaluate sourcing options.
- Create and update component, assembly, and equipment drawings using Solidworks.
- Support process and equipment validations, including IQ, OQ, and PQ activities.
