Staff Process Development Engineer - Pleasanton, CA

ZipRecruiter; Pleasanton (CA); On-site; USD 150,000 - 185,000; Full time

Job summary

Calyxo, Inc., a medical device company in Pleasanton, CA, seeks a Process Development Engineer. The successful candidate will lead technical projects to innovate kidney stone treatment devices, requiring extensive experience in medical manufacturing and engineering disciplines. Join a diverse team focused on continuous improvement and professional growth.

Benefits

Stock options

401(k) benefits

Healthcare

Paid vacation

Qualifications

• 10+ years supporting medical device manufacturing.
• Experience leading technical projects in cross-functional teams.
• Knowledge of ISO9000, FDA QSR, and Design Control.

Responsibilities

• Lead technical projects to develop and improve products.
• Collaborate with R&D and Manufacturing to optimize processes.
• Design manufacturing procedures and tools to meet standards.

Skills

Electronics troubleshooting

Fixture design

Catheter manufacturing

Mechanical systems experience

Electrical systems experience

Education

Bachelor’s degree in Engineering

Tools

SolidWorks

Microsoft Office

Job description

Job Description

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. Founded in 2016, the company aims to improve kidney stone treatment. Our team is led by experienced executives and investors with a track record of commercializing innovative urology devices.

In This Role, You Will:

• Lead technical projects to develop and improve Calyxo products.
• Communicate project status, risks, and decisions across departments.
• Collaborate with R&D, Quality, Manufacturing, and other teams to optimize processes and reduce costs.
• Design manufacturing procedures, tooling, and fixtures to meet demand and quality standards.
• Support production lines through process improvements and troubleshooting.
• Train production staff on new products and processes.
• Create and update manufacturing documentation following policies.
• Apply LEAN, Six Sigma, and other methodologies for continuous improvement.
• Identify equipment needs and evaluate sourcing options.
• Develop component and assembly drawings using SolidWorks.
• Perform process and equipment validations (IQ/OQ/PQ).
• Ensure product quality and regulatory compliance.

Reporting To: Manager, Process Development Engineering

Requirements:

• Bachelor’s degree in Engineering or related experience.
• At least 10 years supporting medical device manufacturing, with mechanical and electrical systems experience.
• Location: Pleasanton, CA
• Travel: 5%
• Full-time employment
• Desired skills include electronics/PCBA troubleshooting, fixture design, and catheter manufacturing experience.
• Experience leading technical projects in cross-functional teams.
• Knowledge of ISO9000, FDA QSR, Design Control, cGMP, ISO13485, or ISO9001.
• Proficiency in Microsoft Office and SolidWorks.
• Compliance with vaccination regulations.

What We Offer:

Join a high-achieving, diverse team at Calyxo, with opportunities for growth and learning. Our compensation package includes:

• Base salary: $150,000 - $185,000
• Stock options
• Benefits: 401(k), healthcare, paid vacation

We value diversity and inclusion, fostering a supportive environment for all employees. Calyxo is an equal opportunity employer. Legal authorization to work in the U.S. is required.

Disclaimer:

Our interview process is structured and transparent. We do not request sensitive information via email before interviews. Be cautious of scams and verify communications from our official email domain.