Process Development Engineer, Senior Staff (Medical Devices)

Location: Austin, Texas, United States; onsite role

Company

hirify.global develops and manufactures medical devices and components, including Nitinol components, stents, balloon catheters, delivery systems, biomedical textiles, access kits, and guidewires.

What you will do

• Develop, analyze, improve, and validate manufacturing processes for complex catheters using IQ/OQ/PQ protocols.
• Design process parameters, tooling, fixtures, test methods, work instructions, visual standards, and semi-automated assembly equipment.
• Optimize manufacturing quality, build time, cost, yield, and throughput targets.
• Support new product introduction, cost reduction, revenue-generating projects, and day-to-day production troubleshooting.
• Perform process characterization studies using statistical techniques such as DOE, Ppk, and ANOVA, and prepare technical reports.
• Collaborate with cross-functional teams, train production personnel, participate in quality investigations, and mentor less experienced engineers.

Requirements

• Bachelor of Science in Mechanical, Chemical, or Bio-Engineering; equivalent experience may be considered in exceptional circumstances.
• 9–12 years of experience in medical device manufacturing and development.
• Extensive hands-on experience with complex catheter manufacturing processes and production equipment.
• Experience with statistical analysis techniques, including Ppk, ANOVA, and DOE.
• Strong understanding of materials including Polyimide, PTFE, FEP, Pebax, nylons, and urethanes.
• Employment visa sponsorship is not available, and candidates with time-limited visa status will not be considered.

Nice to have

• Experience with braiding, lamination, extrusion, laser welding, or hot bonding.
• Experience designing fixtures and simple semi-automated equipment in SolidWorks.
• Green Belt or higher training.
• Knowledge of technical literature and standards related to the area of expertise.

Culture & Benefits

• Collaborative, cross-functional engineering environment.
• Emphasis on company safety, quality policies, and environmental responsibility.
• Opportunity to contribute to medical device innovation and high-volume production.
• Equal opportunity employment.