Process Engineer I - Lean Manufacturing & Efficiency

DiaSorin; Austin (TX); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Competitive salary and benefits

Job summary

DiaSorin in Austin, TX is seeking a Process Engineer I to optimize manufacturing processes, drive efficiency, reduce costs, and implement tooling and equipment updates across Instrument Manufacturing and Quality Control.

You will apply Lean Six Sigma methods, lead process-improvement projects, develop manufacturing instructions, perform IQ/OQ/PQ validation, and collaborate with cross-functional teams to meet production goals and regulatory requirements.

Qualifications

• Bachelor's Degree in Industrial, Manufacturing, or Mechanical Engineering or related technical field.
• 2+ years process engineering or manufacturing experience in relevant industry.
• 2+ years experience in GMP/FDA regulated or ISO environment preferred.
• Proficient in MS Word, Excel, Visio and PowerPoint.
• Strong knowledge of cGMP regulations.

Responsibilities

• Leads major process improvement initiatives from identification to execution.
• Identifies gaps in processes and develops project plans with cost reduction goals.
• Applies Lean principles to maximize yield, capacity, and efficiency.
• Creates and maintains Manufacturing Instructions, routings, and training for new/changed processes.
• Performs IQ/OQ/PQ validation activities.
• Analyzes factory data to drive improvements and reduce variability.
• Leads DOE on existing and upcoming processes.
• Identifies automation opportunities and implements solutions.
• Interacts with assemblers, leads, and supervisors to resolve production problems.

Skills

Lean Six Sigma

Statistical analysis

Root Cause Analysis

Data Analytics

DOE (Design of Experiments)

Team collaboration

Time management

Communication

Independent work

Education

Bachelor's Degree Industrial/Manufacturing/Mechanical Engineering

Tools

SolidWorks

MS Office (Word, Excel, PowerPoint)

Visio

Job description

DiaSorin in Austin, TX is seeking a Process Engineer I to optimize manufacturing processes, drive efficiency, reduce costs, and implement tooling and equipment updates across Instrument Manufacturing and Quality Control.

You will apply Lean Six Sigma methods, lead process-improvement projects, develop manufacturing instructions, perform IQ/OQ/PQ validation, and collaborate with cross-functional teams to meet production goals and regulatory requirements.