Ayşe Kaplan Email & Phone Number

R&D Engineer with experience in New Product Development, Project Management, Bioengineer, and Quality Management Representative - Change Management- Design Inputs documents (SRS, Device Description, LoS and Applicability Matrixes) for MDR - Bachelor's degree in Bioengineering and MSc.'s in Bioengineering, approx. four years of experience in medical device and new product development studies,- Leadership of new product development projects from TRL1 to TRL7 in the orthopedic area (Class III),- Assignment of new product development projects from TRL1 to TRL8 in the orthopedic area (Class III),- Development of new biodegradable bio-composite material for bone tissue scaffold using different production methods,- Have experience in 4 different financially supported project - Ability to work in a team - Suitable to work in the multi-disciplinary project-Assignment of preparation of 2 technical files (spinal implant and implants for bone fracture) as MDR (Class III and Class IIa) with the title of Quality Management Representative,-End-to-end preparation and certification of 4 different technical files in the ophthalmic area (Class IIa and Class IIb) as Quality Management Representative,-Ability to plan all tests including, cleanroom validation, sterilization validation, product verification for the notified body certification process- Ability to prepare for DHF, technical file, risk analysis (ISO 14971, D-FMEA, P-FMEA, protocol, and risk analysis report), change management, usability, biocompatibility (ISO 10993), corrective and preventive action (CAPA) - Have experience in the cardiovascular/cardiology field (implantable devices and catheters), the ophthalmic medical devices (cannulas, backflushes, sponges, cross-linking device), and the orthopedic fields (screws, plates, and spinal implants) To access articles:1. A. Kaplan, C.B.Ustundag, Polylactic Acid / Calcium Sulfate Composite Production for BoneTissue Engineering, IMMC, 20th International Metallurgy and Materials Congress, 10-12 June2021.2. A. Kaplan, F.Ciftci and C.B.Ustundag, Filament Fabrication and 3D Printing of Poly(LacticAcid) and Calcium Sulfate (PLA/CaSO4 ) for Bone Tissue Engineering, 4th InternationalCongress on 3D Printing (Additive Manufacturing) Technologies and Digital Industry, 11-14April 2019.Master Thesis: Production of Polymer Matrix Composite Material for Tissue Engineering ApplicationsBachelor Thesis: Alginate-Dextran Hydrogel Based Biofertilizer

Listed skills include Dfmea, New Product Development, Risk Analysis, Project Management, and 6 others.