Process Engineer Job at ALKU, Bedford, MA

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  • ALKU
  • Bedford, MA

Job Description

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

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