Sr. Research and Development Technician - Pleasanton, CA

Calyxo•Pleasanton, CA

1d•Onsite

About The Position

The Senior R&D Technician is a critical member of the Instruments 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.

Requirements

Associates degree or technical certification in biomedical engineering, mechanical engineering or related field
Minimum 5 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)
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
Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify their identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

Nice To Haves

Experience with catheter build and construction techniques (laminating, tipping, joining, braiding, laser cutting) highly desirable
Experience with 3-D printing highly desirable
Solidworks or other CAD software

Responsibilities

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).