John Campbell

8 Years of experience in Medical Device Design and development from R&D to V&V to 510(k) and finally production. Experience in designing for the following manufacturing processes:

• Injection Molding
• Thermoforming
• CNC Machining
• Hydroforming
• Die Casting
• Sheet Metal
• Photochemical Etching
• Additive Manufacturing (3D Printing: FDM, PolyJet, SLS, SLA, etc)
• Optical Systems
• Packaging

Experience in authoring/editing risk documentation (pFMEA, dFMEA, uFMEA, etc.).

Knowledge of the following standards:

• ISO 13485
• 21 CFR 820
• ASME Y14.5
• IEC 60601-1
• ASTM D4169

8 years working in medical device design and development.

BS of Mechanical Engineering and BS of Economics from NC State University (2019)