Senior Process Development Technician - Pleasanton, CA
About The Position
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 Process Development Technician will support the development of new products by executing prototype builds, conducting testing, and providing feedback on manufacturability to drive process improvements. Experience with catheter manufacturing processes and good documentation skills are essential for this role. The technician will be responsible for training production assemblers on new manufacturing processes, both locally and at international contract manufacturers. Proficiency in Spanish and willingness to travel as needed to support transfers is desired.
Requirements
- Minimum 10 years experience as a manufacturing technician in the medical device industry.
- Work location: Pleasanton, CA
- Travel: up to 25%
- Full time employment
- Experience building and testing prototypes for new products.
- Experience performing manufacturing processes such as hotbox bonding, lamination, laser welding, adhesive bonding, hydrophilic coating, and soldering.
- Experience working with small components under a microscope for extended periods of time.
- Experience working in a clean room environment and following proper gowning and material handling procedures.
- Ability to follow Manufacturing Process Instructions (MPI) and properly complete Lot History Records (LHR) per cGMP.
- Ability to communicate effectively with engineers and execute on new instructions.
- Ability to collaborate with and train other technicians and manufacturing operators on new manufacturing processes.
- General computer skills desired.
- Regularly required to lift and carry up to 10 pounds and occasionally lift and carry up to 25 pounds.
- Compliance with relevant county, state, and Federal rules regarding vaccinations.
Nice To Haves
- Proficiency in Spanish desired
Responsibilities
- Execute prototype builds for new designs and processes.
- Assist with engineering testing and documentation of results.
- Identify, recommend, and execute process improvements.
- Train production assemblers on new manufacturing processes, both locally and at international contract manufacturer.
- Manufacture quality product on time per the build plan.
- Complete documentation as required by the Quality System.
Benefits
- A competitive hourly rate of $38 - $40 and variable incentive plan
- Stock options – ownership and a stake in growing a mission-driven company
- Employee benefits package that includes 401(k), healthcare insurance and paid vacation
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
Number of Employees
11-50 employees
