Responsible for design and development of over 20 SKUs consisting of various Class I and II orthopedic medical instruments that are planned to be released to market with an expected revenue of over $565,000Utilized Creo Parametric to draft 3D parts, assemblies, and complex engineering and manufacturing drawings compliant with GD&T and company standardsCommunicated with Surgeons and Sales Representatives via email, virtual meetings, and calls to effectively collect voice of customer establishing design inputs for specific medical device requests to satisfy surgeons’ unmet needsDeveloped rapid plastic 3D printed and metal prototypes to confirm design functionality and ergonomic suitabilityValidated design inputs through direct feedback with the requesting surgeon and sales consultantCreated and supported design history documentation files for new Trauma and CMF medical devicesCollaborated with Design Quality Engineers and Regulatory Affairs to identify regulatory needs and mitigate product risksInterfaced with marketing teams to determine quantities and price points for market influencing medical instruments

•Design and model specific projects for patrons then print them with the appropriate material for clinical use or prototyping• Process and document multiple 3D printing, scanning, and laser cutting requests from students and faculty• Analyze and slice stereolithographic files to optimize printing time and efficiency and determine best material and orientationbased on the mechanical and chemical properties required of the print described by the patrons• Communicate with patrons via email and in person to discuss their projects and quality of prints• Maintain, troubleshoot, and repair various 3D printers and other relevant equipment

Applied QSR and GMP Design Control principles to the development of new foot and ankle orthopedic implants and instrumentsCreated rapid prototypes of my design iterations using 3D printing and performed preliminary analyses to determine design suitabilityParticipated in and contributed to design phase review activitiesExecuted design changes to legacy products using SolidWorks in response to post-market feedbackPerformed quality assurance tasks, including incoming inspections of manufactured products using quality inspection toolsRecorded and reported non-conformances discovered during the incoming inspection processPerformed and documented complaint- and CAPA- related investigations