Process Engineer II - Lean & Continuous Improvement

Diasorin; Austin (TX); Presencial; USD 90.000 - 125.000; Jornada completa

Descripción de la vacante

Diasorin is seeking a Process Engineer II to optimize manufacturing processes, improve cost efficiency, and enhance quality across Instrument Production, Quality Control, and Depot operations. You will lead data-driven improvements, drive Lean and Six Sigma initiatives, and ensure compliance with regulatory requirements.

Join a team that values innovation, collaboration, and continuous improvement while developing scalable solutions for high-volume and custom manufacturing needs.

Formación

• Bachelor's Degree In Industrial, Manufacturing, Mechanical Engineering, or related technical field preferred
• Master's Degree In Engineering or related field preferred
• 5+ Years 5+ years of experience in process or manufacturing engineering in a regulated industry preferred
• 3+ Years 3+ years of experience in GMP/FDA regulated or ISO certified environment required

Responsabilidades

• Lead and manage complex process improvement projects from concept through implementation.
• Identify process inefficiencies and drive measurable improvements with cost, quality, and throughput outcomes.
• Champin and mentor Lean and Six Sigma principles to improve process yield, equipment capacity, and factory capability.
• Author and maintain detailed Manufacturing Instructions, routings, and training documentation for advanced processes.
• Own and execute process validation protocols (IQ/OQ/PQ) with cross functional alignment.
• Analyze Value Stream Maps to identify opportunities for ongoing manufacturing optimization.
• Drive infrastructure expansion and production layout efficiency initiatives.
• Apply advanced Lean tools (e.g., DMAIC, Kaizen, PDCA) to engineer scalable and sustainable manufacturing processes.
• Design and optimize production cells and material flow to support high-volume and custom manufacturing needs.
• Utilize operational data to recommend and implement performance improving projects.
• Lead root cause investigations of manufacturing or field defects; develop CAPA.
• Establish and maintain standardized processes across teams and sites.
• Develop and train teams on best practices and SOPs to drive process consistency.
• Ensure compliance with all applicable environmental, safety, quality, and regulatory requirements.
• Use SPC, DOE, scripting, and dashboards to monitor and reduce process variability.
• Lead creation and updates of FMEAs and Control Plans for key processes.
• Implement human error proofing strategies (Poka Yoke) in complex workflows.
• Optimize line balance, cycle time, and takt time to support lean operations.
• Develop and present ROI justifications to leadership for proposed capital or process improvements.
• Independently design and conduct DOE for continuous and new product/process validation.
• Collaborate with production teams to resolve process issues and support operator efficiency.
• Lead identification and implementation of automation opportunities.
• Perform hands-on troubleshooting and process refinement as needed on the floor.
• Manage cross functional impacts of procedural, engineering, and documentation change releases.
• Analyze and implement ECOs, MCOs, and DCOs.
• Act as liaison between departments to drive collaboration and alignment.
• Escalate complex or systemic issues to leadership proactively.
• Mentor junior engineers and provide technical guidance to cross functional peers.
• Other duties as assigned.

Conocimientos

Statistical methods

Lean manufacturing

Data analysis

DOE″ design of experiments

Cross-functional collaboration

Educación

Bachelor's in Industrial/Manufacturing/Mechanical Engineering

Master's in Engineering (preferred)

5+ years process/manufacturing eng. in regulated industry

3+ years GMP/FDA ISO environment

Herramientas

Microsoft Excel

Visio

PowerPoint

Word

Descripción del empleo

Diasorin is seeking a Process Engineer II to optimize manufacturing processes, improve cost efficiency, and enhance quality across Instrument Production, Quality Control, and Depot operations. You will lead data-driven improvements, drive Lean and Six Sigma initiatives, and ensure compliance with regulatory requirements.

Join a team that values innovation, collaboration, and continuous improvement while developing scalable solutions for high-volume and custom manufacturing needs.