Process Engineer II

Diasorin • Austin, TX

4d

About The Position

The Process Engineer II is a technical leader responsible for optimizing manufacturing processes, improving cost efficiency and quality, and supporting scalability through data-driven decisions and cross-functional collaboration. The role supports advanced manufacturing for Instrument Production, Quality Control, and Depot operations, and serves as a subject matter expert in Lean methodology, validation, and continuous improvement.

The position leads complex improvement projects, process validation, root-cause investigations, and manufacturing optimization initiatives. It also develops standardized processes and documentation, supports production teams with troubleshooting, and provides technical guidance and mentoring across teams. The role ensures compliance with applicable environmental, safety, quality, and regulatory requirements.

The position operates in a standard manufacturing and office environment. Potential travel of 10% may be required for training, shadowing, and leading events.

Requirements

• At least 3 years of experience in a GMP/FDA-regulated or ISO-certified environment is required.
• High proficiency with Microsoft Office Suite, including Word, Excel, Access, Visio, and PowerPoint.
• Excellent organizational, communication, and prioritization skills.
• Ability to adapt to fast-changing environments and timelines.
• Expertise in statistical methods, SPC, and DOE.
• Advanced troubleshooting and data analysis skills using scripting, databases, and dashboards.
• Strong background in time studies, industrial engineering, and continuous improvement.
• Knowledge of cGMP, ISO, and FDA regulations.
• Ability to lead projects and work independently.
• Ability to mentor others and foster cross-functional collaboration.

Nice To Haves

• Bachelor’s degree in Industrial, Manufacturing, or Mechanical Engineering, or a related technical field preferred.
• Master’s degree in Engineering or a related field preferred.
• At least 5 years of process or manufacturing engineering experience in a regulated industry preferred.
• Lean Six Sigma Black Belt preferred.
• ASQ Certified Quality Engineer preferred.

Responsibilities

• Lead and manage complex process improvement projects from concept through implementation.
• Identify process inefficiencies and deliver measurable improvements in cost, quality, and throughput.
• Champion and mentor Lean and Six Sigma principles to improve process yield, equipment capacity, and factory capability.
• Author and maintain Manufacturing Instructions, routings, and training documentation for advanced processes.
• Own and execute IQ/OQ/PQ process validation protocols with cross-functional alignment.
• Analyze Value Stream Maps to identify manufacturing optimization opportunities.
• Drive infrastructure expansion and production layout efficiency initiatives.
• Apply Lean tools such as DMAIC, Kaizen, and PDCA to develop scalable and sustainable manufacturing processes.
• Design and optimize production cells and material flow for high-volume and custom manufacturing needs.
• Use operational data to recommend and implement performance-improvement projects.
• Lead root-cause investigations of manufacturing or field defects and develop corrective and preventive actions (CAPA).
• Establish and maintain standardized processes across teams and sites.
• Develop and train teams on best practices and SOPs to promote process consistency.
• Ensure compliance with applicable environmental, safety, quality, and regulatory requirements.
• Use SPC, DOE, scripting, and dashboards to monitor and reduce process variability.
• Lead the creation and updating 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 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 the identification and implementation of automation opportunities.
• Perform hands-on troubleshooting and process refinement on the manufacturing floor as needed.
• Manage cross-functional impacts of procedural, engineering, and documentation change releases.
• Analyze and implement Engineering Change Orders (ECO), Manufacturer Changes (MCO), and Departmental Changes (DCO).
• Act as a liaison between departments to drive collaboration and alignment.
• Proactively escalate complex or systemic issues to leadership.
• Mentor junior engineers and provide technical guidance to cross-functional peers.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level