R&D Engineer

R&D Engineer Charlotte, NC | On-site | Full-time | $75,000–$130,000

A medical device manufacturer specializing in injection molded components is hiring an R&D Engineer to design and develop Class II and Class III medical devices from concept through commercialization. You'll support catheter and interventional device programs across cardiology, neurology, and related therapeutic areas.

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

Relocation assistance available. Visa sponsorship is not available.

What you'll do:

• Design and develop medical devices from concept through production, including hands-on catheter and device assembly and prototyping
• Design components, tooling, and fixtures in SolidWorks (or equivalent CAD)
• Develop pilot and production tooling, fixtures, equipment, and assembly processes
• Lead or support verification and validation (including IQ/OQ/PQ), test protocols, and design history file documentation
• Partner with Quality, Manufacturing, Supply Chain, and Project Management on schedules, risks, and technical execution
• Support manufacturing troubleshooting, process improvements, and design changes
• Collaborate with vendors on materials, components, tooling, and manufacturing processes
• Mentor junior engineers and drive complex technical resolution (Senior level)

What you bring:

• Class II/III interventional medical device or catheter manufacturing experience (required)
• BS or MS in Biomedical, Mechanical, or related engineering (Biomedical engineering degree preferred)
• 3+ years medical device engineering (Engineer II) or 6+ years (Senior)
• Proficiency in SolidWorks or equivalent CAD; hands-on prototyping and lab experience
• Experience with design controls, validation (IQ/OQ/PQ), and materials/processes such as thermal bonding, PTFE processing, and fixture design
• Strong analytical, documentation, and cross-functional communication skills

Pay: $75,000–$130,000. Full-time, on-site in Charlotte, NC. Relocation assistance available. Visa sponsorship is not available.