Manufacturing Process Engineer

Manufacturing Process Engineer

Job Summary

Imbed Biosciences is seeking a hands-on Manufacturing Process Engineer to develop, scale, optimize, and sustain manufacturing processes for advanced medical-device products. The role focuses on transitioning processes from pilot-scale development to robust, repeatable, full-scale production, including continuous roll-to-roll coating, web handling, converting, and related manufacturing operations. The engineer will partner with R&D, Manufacturing, Quality, Supply Chain, and equipment suppliers to translate product requirements into capable and validated manufacturing processes. The ideal candidate combines strong engineering fundamentals with practical, data-driven problem solving and is comfortable working directly with manufacturing equipment and production teams.

This role will report to the VP of Integrated Supply Chain.

Roles and Responsibilities

Manufacturing Process Development and Scale Up

• Lead the transition of manufacturing processes from pilot scale to full-scale commercial production.
• Develop, characterize, optimize, and document manufacturing processes, operating parameters, and standardized methods.
• Establish critical process parameters, operating windows, process limits, and manufacturing controls.
• Design and execute engineering trials, Design of Experiments, process-capability studies, and structured experiments.
• Support new-product introduction, technology transfer, production ramp-up, and manufacturing-readiness activities.

Roll to Roll Manufacturing and Process Control

• Develop and optimize roll-to-roll coating, drying, web handling, tension control, alignment, winding, unwinding, and converting processes.
• Establish controls for coating-thickness uniformity, coating weight, web speed, web tension, drying conditions, and dimensional consistency.
• Troubleshoot defects including coating non-uniformity, wrinkles, web-tracking issues, edge defects, delamination, and material variation.
• Evaluate relationships among raw materials, equipment settings, environmental conditions, and finished-product performance.
• Use process-control software, sensors, automated inspection, machine vision, and manufacturing data systems where appropriate.

Process Optimization and Troubleshooting

• Lead structured root-cause analysis and corrective actions for manufacturing-process issues.
• Analyze data to identify sources of variation, defects, downtime, scrap, and yield loss.
• Apply 5-Why, Fishbone, FMEA, DOE, SPC, Pareto analysis, and process-capability analysis.
• Improve process capability, first-pass yield, throughput, equipment reliability, material utilization, and manufacturing cost. Establish monitoring methods that identify process drift and help prevent product-quality issues.

Equipment Validation and Quality

• Support equipment specification, selection, installation, commissioning, and qualification.
• Participate in Factory Acceptance Testing, Site Acceptance Testing, IQ/OQ/PQ, process qualification, and manufacturing scale-up.
• Develop engineering protocols, technical reports, process specifications, work instructions, and manufacturing procedures. Support Process FMEA, change control, deviations, nonconformances, CAPAs, and manufacturing investigations. Ensure processes comply with applicable GMP, ISO 13485, FDA Quality System requirements, and internal procedures. Identify opportunities for automation, in-line inspection, closed-loop process control, and mistake-proofing.

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Chemical Engineering, Materials Science or Engineering, Industrial Engineering, Manufacturing Engineering, or a related technical discipline.
• Three or more years of manufacturing or process-engineering experience in production, pilot manufacturing, or process development.
• Demonstrated experience developing, scaling, troubleshooting, or optimizing manufacturing processes.
• Strong understanding of process controls, variation, equipment capability, root-cause analysis, and statistical methods.

Preferred Qualifications

• Experience with roll-to-roll manufacturing, continuous web processing, precision coating, laminating, converting, printing, or thin-film manufacturing.
• Experience with machine vision, automated inspection, PLC or process-control systems, sensors, or manufacturing-data acquisition.
• Experience with equipment commissioning, validation, and IQ/OQ/PQ.
• Experience in medical devices, pharmaceuticals, biotechnology, specialty materials, films and coatings, or another regulated manufacturing environment.
• Familiarity with ISO 13485

About Imbed Biosciences Inc.

Imbed Biosciences is a privately held medical device company emerging as a leader in the development of advanced therapies for burns, chronic ulcers, and surgical wounds. The Company has a portfolio of products on the market and in development based on its patented Microlyte Matrix technology to combat local pain and infections in complex wounds. Imbed is backed by private investors and federal agencies, and we are building a world-class organization of talented employees and renowned advisors. We offer highly competitive compensation and employee benefits.