Medical device which delivers pulsed plasma as a skin treatment.

Work Summary

Lead cross functional team of engineers in technical development of prototype design, testing methods, and assembly line for CE marked release of medical device, including:

• Project management of technical team from development to launch,
• Foundational research and laboratory testing for feasibility of skin treatment system.
• Conducted statistical analysis in Minitab and excel of test data.
• Created CAD package for prototype system including tolerance stack and design review.
• Created component specifications, inspection plans, and engineering drawings.
• Created, refined and documented cleaning, assembly and testing processes, equipment, and procedures.
• Sourced, ordered, built, and packaged 250 assemblies to support feasibility, verification, and clinical studies.
• Helped to execute master validation plan and report of assembly line, including installation qualifications.
• Authored or supported risk analysis documentation, DFMEA, & PFMEA.
• Authored or supported documentation  for design history and technical file.

Mechanical design, Mechanical design engineer, Product design, Product development, Atlanta, GA, Solidworks, Pro/E, Pro/Engineer, Pro E, Pro engineer, Wildfire, Georgia Tech, Medical product design, product engineering, freelance, consulting, contract engineer, design for manufacturing, design for assembly, Plastic part design, CAD, FDA & ISO Design Controls, Medical Devices, R&D, FMEA, FEA, IQ, OQ, PQ, Verification and validation, morphix, enginuity works, creature, Product development engineer,