Jim Scott

Background

About Jim Scott

Dynamic, effective, and performance-driven engineering professional leader with an extraordinary blend of business, manufacturing, and quality knowledge. Recognized for product development and regulatory process talents for class I to class medical devices and leading large functional teams of 50 members and multiple tiger teams. Able to focus and direct research-intensive groups of six to ten, overcoming complex technical/legal challenges in a small company or managing an entire disease area in a large company. SME (subject matter expert) respected by the medical community (reviewer for Journal of Cataract and Refractive Surgery) as well as competitors and peers in the fields of Intraocular and Contact Lens Design and Process R&D, Predictive Statistical Modeling and Design of experiments (DOE). Proficient in Quality Improvements and Manufacturing Six Sigma Black Belt Certified. Expert in Polymeric Materials and Prototyping Technologies for Medical Devices, Design Controls, Design History Files (DHF), and EU MDR Requirements. Visionary leader in all aspects of R&D including managing functional groups necessary for product design and development using SolidWorks and Creo Parametric solid modeling structural, fluid flow and thermal finite element analysis (FEA) software.