Manufacturing Engineer

Manufacturing Engineer Charlotte, NC | On-site | Full-time | $90,000–$120,000

A medical device manufacturer specializing in injection molded components is hiring a Manufacturing Engineer to develop, transfer, validate, launch, and continuously improve manufacturing processes for Class II and Class III interventional devices, including catheters and other complex disposables. This is a hands-on, production-floor role partnering with R&D, Operations, Quality, and Supply Chain.

CLASS II/III INTERVENTIONAL MEDICAL DEVICE OR CATHETER MANUFACTURING EXPERIENCE IS REQUIRED.

Relocation assistance available. Visa sponsorship is not available.

What you'll do:

• Provide hands-on engineering support to meet quality, delivery, productivity, and cost goals
• Develop and improve manufacturing processes for interventional devices (catheters, implants, complex disposables)
• Transfer products and processes from R&D into repeatable, scalable production
• Select and implement equipment, tooling, and fixtures; support installation and qualification
• Execute IQ/OQ/PQ, TMV, Gage R&R/MSA, and maintain pFMEAs, control plans, and validation records
• Troubleshoot equipment, tooling, materials, and process issues using structured root-cause analysis
• Drive Lean/Six Sigma improvements in yield, scrap, cycle time, capacity, and COGS
• Create and maintain work instructions, BOMs, routings, process specs, and engineering change documentation

What you bring:

• Class II/III interventional medical device or catheter manufacturing experience (required)
• Bachelor's in Mechanical, Biomedical, Manufacturing, or related engineering
• 1–5+ years manufacturing/process engineering experience (level depends on independence and project ownership)
• Working knowledge of process development, design transfer, and medical device validation
• Hands-on production aptitude; SolidWorks and Lean/Six Sigma preferred
• Strong analytical, documentation, and cross-functional communication skills

Pay: $90,000–$120,000. Full-time, on-site in Charlotte, NC. Relocation assistance available. Visa sponsorship is not available.