Industrial Engineer, Senior Staff (Manufacturing Systems)

Location: Austin, Texas, United States; onsite work in an office, engineering lab, and Class 8 cleanroom. Travel up to 50%, primarily to Costa Rica, is required during critical project phases.

Company

Medical technology company developing Nitinol components, stents, catheters, delivery systems, biomedical textiles, access kits, and guidewires from prototype through high-volume production.

What you will do

• Design end-to-end manufacturing process flows, line layouts, takt models, and WIP strategies.
• Perform capacity analysis, identify bottlenecks, and optimize staffing for scalable production.
• Integrate manual and automated operations while defining high-level equipment specifications, placement, and line interfaces.
• Lead process characterization, DOE studies, statistical validation, and line-level documentation.
• Design and execute IQ/OQ/PQ validation protocols and contribute to PFMEAs and manufacturing risk analyses.
• Provide technical leadership for catheter line development, Costa Rica transfers, cross-site standardization, installation, debugging, validation, and training.

Requirements

• Bachelor’s degree in Mechanical, Industrial, Manufacturing Engineering, or a related field.
• 9–12 years of experience in manufacturing systems, industrial engineering, or process development in regulated environments.
• Experience scaling complex small-scale assembly processes into stable, high-volume production lines.
• Experience defining line architecture, equipment requirements, staffing models, and capacity plans with automation and operations teams.
• Proficiency in SolidWorks and experience with process characterization, validation, DOE, IQ/OQ/PQ, and SPC.
• Medical device or other highly regulated manufacturing experience, plus the ability to mentor engineers and lead cross-functional technical efforts. Employment visa sponsorship is not available, and time-limited visa status is not accepted.

Nice to have

• Minitab experience.
• Familiarity with materials used in catheter assemblies.
• Green Belt or Black Belt certification.

Culture & Benefits

• Collaborative work with customers and cross-functional engineering, automation, operations, and technician teams.
• Work spans office, engineering lab, and cleanroom environments.
• Occasional cleanroom gowning and extended standing at development benches or workstations are required.
• Ability to lift up to 50 lbs. is required.
• Technical mentorship is expected without direct managerial responsibility.