Manufacturing Engineering Manager

Manufacturing Engineering Manager Charlotte, NC | On-site | Full-time | $90,000–$130,000

A medical device manufacturer specializing in injection molded components needs a hands-on Manufacturing Engineering Manager to lead the Charlotte Manufacturing Engineering team. You'll mentor engineers while staying deeply involved in design transfer, process development, validation, troubleshooting, and production support for Class II/III interventional devices.

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

Relocation assistance available. Visa sponsorship is not available.

What you'll do:

• Lead, mentor, and set priorities for the Manufacturing Engineering team day to day
• Lead product and process transfers from Product Development into scalable production
• Improve existing processes, equipment, tooling, and methods for quality, throughput, cost, and reliability
• Oversee process verification/validation, capability studies, GR&R, and test method validation
• Provide hands-on troubleshooting and technical escalation for complex production issues
• Manage multiple projects: timelines, resources, risks, and stakeholder communication
• Evaluate equipment, tooling, fixtures, and automation; support capital justification and qualification
• Partner with Product Development, Quality, Operations, and customers on manufacturability and launch readiness

What you bring:

• Class II/III interventional medical device or catheter manufacturing experience (required)
• Bachelor's in Mechanical, Biomedical, Manufacturing, or related engineering (Master's preferred)
• 7+ years engineering experience, preferably in medical devices; design transfer and process development experience
• Experience leading complex projects and mentoring engineers; FDA/ISO 13485 environment preferred
• Strong validation, statistical analysis, Lean/Six Sigma, and hands-on production support skills
• SolidWorks (or equivalent) and ERP experience preferred; excellent cross-functional communication

Pay: $90,000–$130,000. Full-time, on-site in Charlotte, NC. Relocation assistance available. Visa sponsorship is not available.