Process Engineer - New Product Introduction (Medical Technology)

Location: Austin, Texas, United States; onsite full-time role. Less than 5% travel. Applicants must already have full-time work authorization in the United States and must not require current or future employment visa sponsorship.

Company

hirify.global is a medical technology company developing orthopedic implants, surgical instruments, and digital health technologies to improve patient outcomes and restore movement.

What you will do

• Design, develop, improve, and transfer manufacturing processes for new products into production at hirify.global and supplier facilities.
• Serve as the primary process and manufacturing expert on cross-functional new product introduction teams.
• Develop processes, procedures, tooling, and automation while assessing process capabilities and implementing improvements.
• Lead manufacturing technical reviews, development builds, design-for-manufacturability input, and communication of process limits and capabilities.
• Prepare quality-system documentation, including bills of materials, routers, FMEAs, validation protocols, and reports.
• Participate in lean reviews and Kaizen events, contribute to intellectual property submissions, and coach technicians or other engineering employees.

Requirements

• Bachelor’s degree in science, mechanical engineering, or a related engineering discipline.
• At least 10 years of experience in process or manufacturing engineering.
• Expert-level design-for-manufacturability knowledge, including the ability to influence product design and establish strategies for quality, cost, scalability, and manufacturability.
• Advanced proficiency applying ASME Y14.5 standards, datum strategies, and complex dimensional requirements for precision-machined components and assemblies.
• Expertise in manufacturing processes for orthopedic implantable products and surgical instruments.
• Knowledge of lean manufacturing, process control, design of experiments, process validation, product and process FMEA, and problem-solving methodologies such as Six Sigma and DMAIC.
• Experience with CAD software, SolidWorks, Mastercam, measurement systems such as CMMs, vision inspection, and profilometers.
• Ability to lift, carry, and pull up to 50 pounds and stand or sit for extended periods.

Nice to have

• Experience with data analysis using Minitab.
• Master’s degree in engineering.
• Experience with metals or plastics machining.

Culture & Benefits

• Collaborative, continuous-improvement culture focused on scientific excellence and better patient outcomes.
• Medical, dental, and vision insurance.
• Spending and savings accounts, 401(k), vacation, sick leave, and holidays.
• Income protection plans, discounted insurance rates, and legal services.