Manager, Engineering (Medical Devices)

Location: Austin, Texas, United States; onsite

Company

hirify.global develops and manufactures medical devices and components through material science, engineering, and high-volume manufacturing capabilities.

What you will do

• Manage, mentor, and support the career development of engineers and technicians.
• Assign engineering resources to project teams and coordinate the timely completion of technical activities.
• Lead catheter process development from early-stage work and low-volume builds in Austin through transfer to Costa Rica for long-term high-volume manufacturing.
• Identify, optimize, validate, and implement manufacturing processes, equipment, tooling, fixtures, and process parameters.
• Prepare engineering memorandums, work instructions, test methods, visual standards, and Medical Device File documentation.
• Manage the engineering team budget and capital appropriations based on testing and demonstrated feasibility.

Requirements

• BS degree in a relevant discipline with 12+ years of related engineering and management experience, or MS with 8+ years, or Ph.D. with 6+ years.
• Medical device industry experience and at least 2 years of leadership and people management experience.
• Hands-on experience with catheter production equipment, including hot boxes, die-bonders, braiders, coil winders, laminators, ovens, UV adhesive light welders, and laser welders.
• Strong knowledge of catheter production materials, including Pebax, Nylon, Polyurethanes, PEEK, PTFE, FEP, CA and UV adhesives, stainless steel, and NiTi.
• Experience with process characterization studies, DOE, validation strategies including IQ/OQ/PQ, technical standards, and manufacturing documentation.
• Excellent written and spoken English is required. Employment visa sponsorship is unavailable, and candidates with time-limited visa status will not be considered.

Nice to have

• Six Sigma Black Belt certification.

Culture & Benefits

• Collaborative work with customers from rapid prototyping through high-volume production.
• Opportunity to develop innovative medical devices and catheter technologies.
• Cross-functional training support for technicians, operators, and transfer engineers.
• Focus on manufacturing quality, efficiency, yield, cost, and process capability.