Ø  Total 9.7+ Years of professional work experience in Engineering Design & Medical devices and managing products right from development to delivery encompassing in various phases of product lifecycle.Ø  3D part / assembly modelling and 2D drawing (Production drawing, Sales drawing and Stage drawing) drafting using Creo/ Solidworks / Autodesk inventor / AutoCAD Mechanical as per customer requirements.Ø  Design Release/Bill of Material (BOM) creation/Drawing release to Production/ Technical documentation/Taking care of Engineering Change Orders (ECO) until released.Ø  Hands on experience in medical device related standards and regulations such as follows ISO13485- Medical Device QMS, ISO 14971- Application of Risk management, ISO 15223- Medical device Symbols, FDA 21 CFR 820.30- Design Control, 21 CFR 801 – Labeling , EU MDR 2017/745 and 510k submission.Ø  Experience in leading the Design History File (DHF) remediation project – worked with diverse technical team to create, update and maintain design control documents as a part of medical product design team.Ø  Experienced in preparation of documents such as GSPR, STeD files for EUMDR 2017/745 project thru Gap analysis and Labeling/IFU changes, Labeling Ink Qualification projects for Class II and Class IIa Medical products.Ø  Strong knowledge towards Product design and have done NPD, Reverse Engineering, Tolerance stack-up analysis and VA/VE to provide better product design.Ø  Proficient in PLM tools SAP, Agile and Team Center and ECR/O Process.Ø  Experienced in Supplier follow up and qualification in Medical products to ensure quality, PMS activities such as PMS plans, reports and complaints handling.Ø  Strong knowledge in cost reduction activities and quality field – 7QC tools, CAPA, FMEA, Six Sigma.Ø  Certified in Six Sigma Green Belt training and part of Value Creation / Kaizen Team.Ø  Certified Professional in Lean Methodologies and Total Quality management (TQM) concepts.