Manufacturing Project Engineer Imbed Biosciences, Inc.

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.

• 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.

• 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.

• 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.

• 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.

• 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…