Extrusion Engineer- #260606

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

The Senior Extrusion Engineer provides technical expertise, operational knowledge, and engineering leadership for advanced medical extrusion operations. In this hands‑on, on‑site role, you will take the lead in extrusion engineering functions—including process validation (IQ/OQ/PQ/TMV), troubleshooting, continuous improvement, capital project execution, and capability expansion.

You will serve as a Subject Matter Expert (SME), partnering with cross‑functional value‑stream teams to solve complex technical challenges, assess new business opportunities, interface with tooling machine shops, and mentor technical staff.

Key Responsibilities

• Process Engineering & Validation: Troubleshoot, optimize, and validate melt extrusion processes. Author and execute validation protocols (IQ, OQ, PQ, TMV) independently, while guiding technicians and engineers through execution.
• Tooling & Equipment: Design tooling and fixturing internally and collaborate with external machine shops to support new product development (NPD) and process upgrades. Lead the evaluation, acquisition, and commissioning of new manufacturing equipment.
• Continuous Improvement & Lean: Spearhead scrap reduction, safety enhancement, cycle‑time improvement, and yield optimization projects utilizing Lean and Six Sigma principles.
• Technical Troubleshooting: Investigate and resolve root‑cause production issues related to polymer processing and multi‑lumen extrusion.
• Cross-Functional Collaboration: Represent extrusion engineering in daily Value Stream meetings, product transfer teams, and capital expenditure planning sessions.
• Mentorship & SME Support: Act as the extrusion technical authority; provide daily direction, training, and technical mentorship to technicians and junior engineers.

Required Qualifications

• Education: Bachelor’s degree in Engineering (Plastics, Mechanical, Chemical, or related discipline).
• Experience: 5+ years of hands‑on engineering experience in an extrusion manufacturing environment.
• Process Validation: Demonstrated experience with formal medical or regulated validation protocols (IQ/OQ/PQ/TMV), process controls, and Statistical Process Control (SPC).
• Technical Acumen: Strong background in polymer materials, plastic chemistry/properties, and tooling design.
• CAD & GD&T: Working knowledge of Geometric Dimensioning and Tolerancing (GD&T) with proficiency in SolidWorks or equivalent CAD software.
• Software: Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and statistical software (e.g., Minitab).
• Communication & Culture: Strong written and verbal communication skills with the ability to write comprehensive technical documentation; commitment to quality- and safety-first workplace standards.

Preferred Qualifications

• Bachelor’s or Master’s degree in Plastics Engineering.
• Extrusion experience within a regulated medical device manufacturing environment (familiarity with FDA regulations, GMP, and Design Controls).
• Direct experience developing tooling and processes for complex multi‑lumen tubing.
• Lean Six Sigma Green Belt or Black Belt certification.
• Broader exposure to secondary medical device manufacturing methods (e.g., RF tipping/forming, injection molding, wire braiding, centerless grinding, bonding/assembly).
• Experience utilizing Microsoft Project and Visio.