Process Development Engineer

Responsible for developing, validating, and sustaining manufacturing processes and equipment used in medical device production. This role ensures products can be reliably transitioned from design to scalable production through process development, tooling/fixture design, validation (IQ/OQ/PQ), and cross‑functional support. The engineer will also support production transfers, supplier manufacturing, and process improvement activities while ensuring compliance with FDA and ISO requirements. Required Experience Bachelor’s degree in Mechanical, Manufacturing, Industrial Engineering, or related field 3+ years of experience in medical device or pharmaceutical manufacturing Hands‑on experience with process development, process flow design, and manufacturing documentation Experience executing or supporting validation activities (IQ/OQ/PQ) Knowledge of FDA 21 CFR Part 820 and ISO 13485 requirements Experience developing or supporting process FMEAs and risk management activities Ability to create and maintain work instructions, process documentation, and technical reports Experience supporting production troubleshooting and manufacturing issue resolution Proficiency in Microsoft Office and strong documentation skills Preferred Experience Experience with production transfers from R&D to manufacturing Exposure to fixture/tooling design and manufacturing equipment development Experience with CAD tools (SolidWorks, Solid Edge, or similar) Familiarity with Lean Manufacturing principles and continuous improvement Experience working with suppliers or contract manufacturers Knowledge of process capability analysis and validation protocols Strong cross‑functional collaboration with Quality, R&D, and Operations teams #J-18808-Ljbffr