Sr. Research and Development Technician, Instruments - Pleasanton, CA

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 

• Experience with 3-D printing highly desirable 

• Working knowledge of computers, word processing, Good Documentation Practices (GDP) and spreadsheets 

• Competent in reading and understanding engineering drawings and specifications to accurately assemble and build prototypes 

• Work location: Pleasanton, CA. This job is fully on-site 

• Compliance with relevant county, state, and Federal rules regarding vaccinations. 

Preferred Qualifications:  

• Solidworks or other CAD software 

What We Offer: 

 

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team.  You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture.  You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself.   

 

We also offer an attractive compensation package, which includes: