Principal R & D Engineer, Technical-Lead for Product/Project Transfer. Trained engineers in CGMP, ISO-13485, I.Q., O.Q., P.Q., and PPQ. Good understanding of Regulatory (Class II and III) requirements and Quality fundamentals. Strong knowledge in the areas of plastic materials, processes & design. Experience includes processing of wide variety of polymers, project transfers from R & D to manufacturing, technical presentations, new process technology development, working with vendors, design and develop manufacturing tools & equipments, expertise in the area of product and process improvements, qualifications and validations. Participated in DRM, DFMECA, PFMECA-process at Medtronic and al...