Senior Process Engineer

Cambridge Recruiters; Menlo Park (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Cambridge Recruiters in Menlo Park is seeking a Staff Process Engineer for catheter process and equipment development. The role focuses on hands-on engineering to develop and optimize custom manufacturing equipment and processes for a novel catheter-based technology.

The ideal candidate will have strong medical device process/manufacturing experience, enjoy working with fixtures and tooling, and contribute to DOE, IQ/OQ/PQ, validation, and production-scale rollouts.

Qualifications

• Strong catheter process development experience.
• Hands-on with equipment, fixtures, and tooling.
• Experience with IQ/OQ/PQ and process validation.
• Ability to scale processes and equipment into production.

Responsibilities

• Lead catheter process development and optimization.
• Design and qualify fixtures and tooling (SolidWorks).
• Collaborate with equipment builders, machine shops, and vendors.
• Support IQ/OQ/PQ and process validation activities.
• Drive yield, throughput, and repeatability improvements.
• Scale processes from development to production.

Skills

Catheter process development

DOE

SolidWorks

IQ/OQ/PQ

Equipment development

Manufacturing scale-up

Job description

Staff Process Engineer – Catheter Process & Equipment Development

I’m working with a growing cardiovascular medical device company in Menlo Park that is hiring a Staff Process Engineer with strong catheter process development experience.

The company has recently achieved an important U.S. regulatory milestone and is now moving into an exciting stage of manufacturing scale-up and commercialization!

This is a particularly interesting opportunity for someone who enjoys the hands-on process and equipment side of engineering. Rather than simply maintaining an established manufacturing line, you’ll be helping develop and optimize custom manufacturing equipment and processes for a novel catheter-based technology.

Job Focus:

• Catheter process development and optimization
• Development of custom manufacturing equipment
• Working directly with equipment builders, machine shops and outside vendors
• Fixture and tooling design (SolidWorks)
• DOE, process characterization and troubleshooting
• IQ/OQ/PQ and process validation
• Improving yield, repeatability and throughput
• Scaling processes and equipment into production
• Supporting the transition into commercial manufacturing

The ideal candidate will have strong medical device process/manufacturing engineering experience, and enjoy being hands-on with equipment, fixtures, tooling and process development.

This is a chance to join a well-funded, growing medical device company at a great stage — proven technology, an important regulatory milestone behind them, and plenty of interesting process and manufacturing development work still ahead.

Local Candidates strongly preferred

NO H1B VISA or Sponsorships - must have US Work Authorization or be a US Citizen