Staff Process Development Engineer (Medical Devices)

Location: Laguna Niguel, California, United States; onsite engineering and manufacturing role.

Salary: $90,800–$151,300 per year.

Company

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

What you will do

• Develop scientific approaches, process parameters, tooling, and manufacturing methods for catheters, balloons, and polymer extrusion.
• Perform process analysis, improvement, characterization, design of experiments, and IQ/OQ/PQ validation.
• Develop validation protocols, test methods, work instructions, visual standards, reports, and other engineering documentation.
• Lead new product introduction, cost reduction, and revenue-generating engineering projects.
• Optimize manufacturing processes for quality, build time, cost, yield, and manufacturing control targets.
• Mentor less experienced engineers and coordinate engineering work across cross-functional and multi-site teams.

Requirements

• Bachelor’s or master’s degree in mechanical engineering, biomedical engineering, or a related field.
• 6+ years of medical device development experience, with authoritative expertise in catheters, balloons, and medical device extrusion.
• Experience with medical-grade polymers including Pebax, Nylon 12, polyurethanes, and PET, plus polymer testing methods such as FTIR, DSC, and mechanical analysis.
• Experience authoring medical device design control documents and working with relevant technical literature and standards.
• Strong AutoCAD, SolidWorks, and Minitab skills, including drawings for balloons, extrusion, and tooling.
• Employment visa sponsorship is not available, and candidates with time-limited visa status will not be considered.

Nice to have

• Green Belt or higher training.
• Hands-on experience with catheter, balloon, and extrusion production equipment, including thermal bonding and swaging.

Culture & Benefits

• Collaborative team environment with cross-functional engineering work.
• Opportunities to support multiple sites and cross-train in polymer extrusion.
• Role includes mentoring and leadership responsibilities.
• Work emphasizes safe, environmentally sound process start-up and maintaining a clean work environment.