Manufacturing Engineer - Capital - 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 Manufacturing Engineer supports the development, improvement, and sustainment of manufacturing processes for CVAC 2.0, with a focus on quality, efficiency, and scalability. This role collaborates cross‑functionally with R&D, Quality, and Manufacturing teams to implement process improvements, support production, and transition new products and processes into manufacturing. The position also contributes to documentation, validation, equipment support, and continuous improvement while ensuring regulatory compliance and product quality.

In This Role, You Will:

* Support technical projects leading to new/improved processes for CVAC 2.0.

* Collaborate cross-functionally with R&D, Quality, Manufacturing Assemblers/Technicians, and other functional areas to design and develop processes to optimize robustness and flow, reduce costs and variability, and improve capability.

* Contribute to the design and development of manufacturing procedures, tooling, and fixtures that result in sufficient capacity to meet customer demand while also promoting product quality, process efficiency, and operator safety.

* Provide sustaining production line support including, but not limited to, implementing process improvements, troubleshooting equipment, and addressing operator inquiries.

* Train and support production personnel during transition of new products/processes to production.

* Create and update high-quality manufacturing process documentation and assure that processes and documentation follow established policies and procedures.

* Apply LEAN, Six Sigma, and other best practice tools and principles for day-to-day problem solving and continuous improvement.

* Assist in identifying equipment needs on the production floor and evaluating internal and external options for sourcing such equipment.

* Generate and modify component/assembly/equipment drawings using Solidworks.

* Support the execution of process and equipment validations (IQ/OQ/PQ).

* Coordinate with external vendors as needed.

* Perform routine equipment maintenance by following manufacturer's instructions and established procedures.

* Communicate project status, schedule baselines, schedule issues, project risks, and major decisions across all company disciplines.

* Support product quality and support regulatory compliance.

Who You Will Report To:

* Principal Manufacturing Engineer

Requirements:

* Education:

Bachelor of Science in Engineering or a combination of relevant education and experience

* 5+ years' experience supporting medical device manufacturing

* Experience with electronic components/assembly in the context of medical device capital equipment.

* Work location:

Pleasanton, CA

* Travel: up to 20%

* Full time employment

* Proven track record of leading and delivering highly technical projects in a cross functional environment.

* Experience working in a structured design process such as ISO
9000 or FDA QSR and knowledge of regulatory approval process and requirements.

* Working knowledge of Design Control and cGMP requirements for medical device manufacturing per FDA QSR and ISO
13485 or ISO
9001 and EN46001.

* Excellent computer skills with specific skills in Microsoft Office and proficiency in Solid Works.

* Desirable:
Experience working with capital equipment having field upgradable software.

* Desirable:

Experience with phased medical device product development process and performing design transfer.

* Desirable:
Experience designing, building, and implementing manufacturing fixtures and processing aids.

* Compliance with relevant county, state, and…