Process Development Engineer II (Medical Devices)

Location: Austin, Texas, United States

Company

hirify.global develops and manufactures medical devices and components, including complex catheters, stents, biomedical textiles, and precision polymer tubing.

What you will do

• Develop process parameters, tooling, methods, fixtures, and semi-automated equipment for complex catheter manufacturing.
• Perform process characterization, statistical analysis, process improvement, and IQ/OQ/PQ validation.
• Lead new product introduction, cost reduction, revenue-generating, and moderate-complexity engineering projects.
• Optimize manufacturing processes for quality, throughput, build time, cost, and yield targets.
• Create protocols, reports, work instructions, test methods, and visual standards.
• Collaborate with cross-functional teams, participate in quality investigations and CAPA activities, and mentor less experienced engineers.

Requirements

• Bachelor’s degree in Materials, Mechanical, Biomedical Engineering, or a related field; a master’s degree is preferred.
• 3–6+ years of medical device development experience with a bachelor’s degree, or 1–4 years with a master’s degree.
• Strong SolidWorks skills and familiarity with medical device design controls and documentation.
• Understanding of validation strategy, including IQ/OQ/PQ, protocols, and reports.
• Hands-on experience with medical device production equipment and statistical methods such as Ppk, ANOVA, and DOE.
• Leadership, attention to detail, professional attitude, and collaborative working style.

Nice to have

• Minitab experience.
• Green Belt or higher training.
• Experience processing polyimide, PTFE, FEP, Pebax, nylon, and urethane catheter materials.
• Familiarity with technical literature and standards relevant to medical device process development.

Culture & Benefits

• Collaborative, high-impact environment with direct influence on product development and manufacturing outcomes.
• Opportunities to develop broad skills across material science, engineering, and manufacturing.
• Work on projects ranging from rapid prototyping to high-volume production.
• Employment visa sponsorship is not available, and candidates with time-limited visa status will not be considered.
• Equal opportunity employer.