Manufacturing Engineer - Lean Ops for Medical Devices

Hufriedygroup; Northbrook (IL); On-site; USD 75,000 - 100,000; Full time

Job summary

HuFriedyGroup in Northbrook, IL seeks a Manufacturing Engineer to drive technical excellence across operations. You will oversee machinery, perform troubleshooting, support CAPA, and document qualifications and risk assessments to ensure compliant manufacturing.

Requirements include a BS in Engineering, 2+ years in manufacturing engineering (medical device a plus), CAD experience (SolidWorks), and Lean/Six Sigma training. Join a collaborative team committed to quality and continuous improvement.

Qualifications

• BS in Engineering, preferably Mechanical, Chemical, Electrical or Manufacturing Engineering.
• Minimum of two (2) years of Manufacturing Engineering experience, preferably in medical device manufacturing.
• CAD experience is a plus, preferably SolidWorks.
• Familiarity with ISO 13485, FDA Design Control, CAPA, SCAR, and audit procedures.
• Experience in structured problem-solving and use of statistical tools.
• Training and experience in Lean and Six Sigma, or equivalent.
• Experience in Design for Manufacturing, DFMEA, PFMEA, DOE, and Validations

Responsibilities

• Provide general oversight and monitoring of machinery, coordinating maintenance, upgrades, and repair when needed.
• Troubleshoot problems within the manufacturing process.
• Assist with CAPA to resolve production and customer issues using root cause analysis.
• Create written documents, test plans, and reports demonstrating technical rationale for decisions.
• Provide hands-on troubleshooting to manufacturing equipment and processes.
• Drive continuous improvement to optimize yield, quality, cycle time and ergonomics.
• Coordinate efforts with product development on new processes and tooling.

Skills

Lean Six Sigma

Problem solving

Statistical tools

Team collaboration

Education

BS in Engineering

Tools

SolidWorks

Job description

HuFriedyGroup in Northbrook, IL seeks a Manufacturing Engineer to drive technical excellence across operations. You will oversee machinery, perform troubleshooting, support CAPA, and document qualifications and risk assessments to ensure compliant manufacturing.

Requirements include a BS in Engineering, 2+ years in manufacturing engineering (medical device a plus), CAD experience (SolidWorks), and Lean/Six Sigma training. Join a collaborative team committed to quality and continuous improvement.