Lead Medical Extrusion Engineer: Process Validation

Medix Staffing Solutions, Inc.; Fort Snelling Unorganized Territory (MN); On-site; USD 110,000 - 140,000; Full time

Job summary

Medix Staffing Solutions, Inc. seeks an Senior Extrusion Engineer to lead advanced medical extrusion operations on-site. This role directs process validation (IQ/OQ/PQ/TMV), troubleshooting, and continuous improvement while mentoring technicians and engineers.

You will partner with cross-functional teams, interface with toolmakers, and drive capital projects to expand capabilities in a regulated medical device environment.

Qualifications

• Bachelor’s degree in Engineering (Plastics, Mechanical, Chemical, or related discipline).
• 5+ years of hands‑on engineering experience in extrusion manufacturing.
• Experience with IQ/OQ/PQ/TMV, process controls, and SPC.
• Strong background in polymer materials, plastics properties, and tooling design.
• GD&T knowledge; SolidWorks or equivalent CAD software.

Responsibilities

• Troubleshoot, optimize, and validate melt extrusion processes.
• Author and execute validation protocols (IQ, OQ, PQ, TMV).
• Design tooling and fixturing; collaborate with external machine shops for NPD and upgrades.
• Lead evaluation, acquisition, and commissioning of new equipment.
• Drive scrap reduction, safety, cycle-time improvement, and yield optimization via Lean/Six Sigma.
• Represent extrusion engineering in value stream meetings and capital planning; mentor staff.

Skills

Process validation

Statistical analysis

Lean Six Sigma

Cross-functional collaboration

Technical documentation

Education

Bachelor's degree in Engineering

Master's degree in Plastics Engineering

Tools

SolidWorks

GD&T

Minitab

Microsoft Office

Job description

Medix Staffing Solutions, Inc. seeks an Senior Extrusion Engineer to lead advanced medical extrusion operations on-site. This role directs process validation (IQ/OQ/PQ/TMV), troubleshooting, and continuous improvement while mentoring technicians and engineers.

You will partner with cross-functional teams, interface with toolmakers, and drive capital projects to expand capabilities in a regulated medical device environment.