Senior Process Development Engineer – Catheters

Confluent Medical Technologies; Austin (TX); On-site; USD 150,000 - 190,000; Full time

Job summary

Confluent Medical Technologies in Austin, TX is seeking a Process Development Engineer, Senior Staff to lead manufacturing process development for complex catheters. You will perform IQ/OQ/PQ, design fixtures, and work with cross-functional teams to improve yield and reduce cost.

You will mentor junior engineers, develop process parameters and tooling, and contribute to NPI, CAPAs, and root-cause investigations while maintaining quality and safety standards.

Qualifications

• 9–12 years of experience in medical device manufacturing and development.
• Hands-on experience with manufacturing equipment used in complex catheters (braiding, lamination, extrusion, laser welding, hot bonding).
• Strong materials process understanding of Polyimide, PTFE, FEP, Pebax, nylons, and urethanes.
• Experience applying statistical analysis techniques (Ppk, ANOVA, DOE).
• Experience designing fixtures and semi-automated equipment using SolidWorks.

Responsibilities

• Develop manufacturing processes for products in complex catheters.
• Perform process analysis, improvements and validation (IQ/OQ/PQ).
• Create reports and communicate engineering findings to cross-functional teams.
• Mentor less experienced engineers and train production personnel.
• Support new product introduction, cost reduction, and revenue-generating projects.

Skills

DOE

ANOVA

Ppk

SolidWorks

Education

BS in Mechanical Engineering

BS in Chemical Engineering

BS in Bio-Engineering

Tools

SolidWorks

Job description

Confluent Medical Technologies in Austin, TX is seeking a Process Development Engineer, Senior Staff to lead manufacturing process development for complex catheters. You will perform IQ/OQ/PQ, design fixtures, and work with cross-functional teams to improve yield and reduce cost.

You will mentor junior engineers, develop process parameters and tooling, and contribute to NPI, CAPAs, and root-cause investigations while maintaining quality and safety standards.