Process Engineer I: Lean Manufacturing & Validation

DiaSorin; Austin, Northern (TX, KY); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Healthy salary and benefits

Job summary

DiaSorin seeks a Process Engineer I in Austin, TX to identify opportunities and implement changes that improve manufacturing processes, reduce costs, and optimize tooling and production equipment.

The role collaborates with Instrument Manufacturing Production, Quality Control, and Depot teams to drive Lean initiatives and process validation activities. A Bachelor’s degree and 2+ years in process/manufacturing are preferred, with growth opportunities and competitive benefits.

Qualifications

• Bachelor's degree in Industrial, Manufacturing, or Mechanical Engineering; required
• 2+ years process engineering or manufacturing experience; preferred
• 2+ years in GMP/FDA regulated or ISO environment; preferred
• Proficient in MS Word, Excel, Visio and PowerPoint; high proficiency
• Strong knowledge of cGMP regulations; high proficiency
• Lean/Six Sigma and data-driven problem-solving skills

Responsibilities

• Lead/process improvement initiatives from identification to execution
• Identify gaps, develop project plans, and monitor deliverables
• Apply Lean principles to maximize yield and capacity
• Create/manages Manufacturing Instructions, routings, and training
• Manage/process validation activities (IQ/OQ/PQ)
• Analyze Value Stream Maps; optimize factory utilization
• Develop and maintain DOE, Capabilities studies, and DOE leadership
• Interface with assemblers and supervisors to resolve production issues
• Identify automation opportunities and implement solutions
• Ensure compliance with environmental, safety, and quality standards

Skills

Lean Manufacturing

Six Sigma

Statistical Analysis

DOE

Root Cause Analysis

Data Analytics

Tableau Dashboard Development

Line Balancing

Process Optimization

Manufacturing Improvements

Education

Bachelor's Degree Industrial/Mechanical/Manufacturing Engineering

ASQ Certified Quality Engineer (preferred)

Tools

SolidWorks

Microsoft Office (Word/Excel/Visio/PowerPoint)

Tableau

Job description

DiaSorin seeks a Process Engineer I in Austin, TX to identify opportunities and implement changes that improve manufacturing processes, reduce costs, and optimize tooling and production equipment.

The role collaborates with Instrument Manufacturing Production, Quality Control, and Depot teams to drive Lean initiatives and process validation activities. A Bachelor’s degree and 2+ years in process/manufacturing are preferred, with growth opportunities and competitive benefits.