Calyxo, Inc. is a medical device company addressing 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.
Requirements
- Competent in reading and understanding engineering drawings and specifications to accurately assemble and build prototypes
- Competant with basic shop tools (test machines, hand tools, machining tools, soldering etc)
- qualifications: catheter build and construction techniques (laminating, tipping, joining, braiding, laser cutting)
- 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.
- Perform root cause analysis of technical issues and recommend corrective actions.
- Maintain lab equipment, fixtures, and tools to ensure consistent performance.
- Author and revise work instructions, test protocols, and technical documentation.
- 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).
Other
- 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
- Work location: Pleasanton, CA. This job is fully on-site
- Working knowledge of computers, word processing, Good Documentation Practices (GDP) and spreadsheets
- Compliance with relevant county, state, and Federal rules regarding vaccinations.
