Research and Development Technician

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 Senior R&D Technician is a critical member of the team, responsible for hands-on support in the design, testing, and manufacturing of innovative medical devices. This role blends technical skill with collaboration, playing a vital part in building and evaluating prototypes, improving processes, and maintaining equipment to ensure high-quality and regulatory-compliant products. Working closely with R&D, engineering, and manufacturing teams, the Senior Technician contributes to key milestones from early-stage development through product launch and beyond in a dynamic, fast-paced medical device environment. 

In This Role, You Will: 

• Support product development by building prototypes, conducting tests, and documenting results in collaboration with R&D and engineering teams. 

• Support process development through hands-on prototyping and problem solving. 

• Perform root cause analysis of technical issues and recommend corrective actions. 

• Maintain lab equipment, fixtures, and tools to ensure consistent performance. 

• Assist in validation activities including IQ/OQ/PQ and design verification testing. 

• Support manufacturing transfer activities including pilot builds and process documentation. 

• Ensure compliance with company quality systems (e.g., ISO 13485, FDA 21 CFR Part 820). 

Who You Will Report To: 

• Director, Instruments Engineering

Requirements: 

• Education:  Associates degree or technical certification in biomedical engineering, mechanical engineering or related field 

• 8+ years experience in a medical device, biotech or other related regulated field 

• Competent with hands on prototyping and basic shop tools (test machines, hand tools, machining tools, soldering etc) 

• Experience with catheter build and construction techniques (laminating, tipping, joining, braiding, laser cutting) highly desirable