Process Engineer (Bedford)

Process Engineering

• Lead development, optimization, and scaling of manufacturing processes for IVD devices, reagents, and consumables.
• Design and implement process characterization studies using tools like Design of Experiments (DOE) and Statistical Process Control (SPC).
• Develop robust and reproducible processes that meet product specifications, yield, and throughput targets.
• Collaborate with R&D to integrate new technologies into scalable manufacturing processes.
• Plan, execute, and document IQ / OQ / PQ validation activities for manufacturing processes, equipment, and automated systems.
• Create, review, and approve SOPs, protocols, work instructions, and reports.
• Product Transfer & NPI / NPD Support : Lead technology transfer from R&D to manufacturing.
• Evaluate and qualify equipment, materials, and process parameters for new product introduction.
• Support risk assessments, design reviews, and mitigation plans during NPI / NPD projects.
• Serve as the primary technical resource for cross-functional project teams including R&D, Quality, Manufacturing, and Supply Chain.
• Manufacturing & Continuous Improvement : Troubleshoot process deviations, yield issues, and quality incidents in manufacturing.
• Identify opportunities to improve efficiency, reduce costs, and enhance quality through process automation, lean manufacturing, and continuous improvement initiatives.
• LabVIEW & Automation : Develop, maintain, and enhance LabVIEW applications for data acquisition, process monitoring, and automated test systems.
• Interface with control systems, sensors, and instrumentation to optimize process performance and data reliability.
• Support implementation of automated test, monitoring, and control strategies for new and existing products.
• Required Skills : Medical Device / IVD 7-10+ years
• Process Engineering
• NPI / NPD Project Experience
• Product Transfer Experience (Transfer to Mfg)
• LabVIEW Experience