Senior Process Development Technician - Pleasanton, CA

Calyxo, Inc.; Pleasanton (CA); On-site; USD 75,000 - 85,000; Full time

Benefits offered by this job

Competitive hourly rate

Stock options

Benefits: 401(k), healthcare, paid on:

Job summary

Calyxo, Inc. in Pleasanton, CA seeks a Senior Process Development Technician to support new product development by executing prototype builds, testing, and providing manufacturability feedback to improve processes.

The role requires extensive catheter manufacturing experience, strong documentation, and the ability to train others while delivering high-quality products on schedule. Candidates must have 10+ years as a manufacturing technician in the medical device field and be comfortable working

Qualifications

• 10+ years of experience as a manufacturing technician in the medical device industry.
• Experience building and testing prototypes for new products.
• Experience with hotbox bonding, lamination, laser welding, adhesive bonding, hydrophilic coating, and soldering.
• Ability to work with small components under a microscope for extended periods.
• Experience in clean room environments with proper gowning and material handling.
• Ability to follow MPI and complete LHR per cGMP.
• Strong communication with engineers and ability to train others.
• Regularly lift up to 10 lbs; up to 25 lbs occasionally.

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
• Manufacture quality product on time per the build plan
• Complete documentation as required by the Quality System

Job description

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 vaccinations.

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:

• A competitive hourly rate range of $36.06 - $40.86 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

Calyxo is deeply committed to fostering an environment where diversity and inclusion are not only valued but also prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities, which strengthen our focus and fuel our growth.

Calyxo is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.

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.

We appreciate your interest in joining Calyxo and look forward to getting to know you through our official channels.