Senior Process Development Technician - Pleasanton, CA
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Key details
- Location
- Pleasanton, CA, United States
- Work style
- Onsite
- Level
- Senior
- Job type
- Full-time
- Experience
- 10–13 yrs
- Function
- Skilled trades & Manufacturing
- Focus area
- other
- Posted
- 2w ago
Skills
About the role
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 supports new product development by executing prototype builds, assisting with testing, and providing manufacturability feedback to improve processes. This role applies catheter manufacturing experience and strong documentation skills to build quality products consistently and on schedule.
In This Role, You Will:
- 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
- Manufacture quality product on time per the build plan
- Complete documentation as required by the Quality System
Who You Will Report To:
- Manager, Process Development Engineering
Requirements:
- Minimum 10 years experience as a manufacturing technician in the medical device industry.
- Work location: Pleasanton, CA
- Travel: 5%
- 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
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