Kishore Ng

About Kishore Ng

Working in HCL TECHNOLOGIES as Lead Engineer taking care of below activities CAPA…

Experience

1. Lead Engineer

   HCLTech

   Jan 2021 — Present · Chennai, IN

   Working as part of In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) Gap Assessment and Remediation activities in IFU\'s.*HCL Lead Engineer:*•Leading a team of 15 Members. •Updating Daily status to clients, Vendor and Management.•Playing PQA - Project Quality Assurance role for PCI Audit.*Project 4-MEDTECH:**MEDTECH-SCM Procurement Lead:*•Regulating the vendor and Design team requirements.Purchasing the parts need in NPD.•Estimation, Quotation, Performa Invoice, Payment related activities.*Project 3-INTEGRA Life Science**Integra_Sustenanace :*•Done GD & T Tolerance StackUp Analysis for medical devices components.•Designing Medical Devices components in solidworks.•Analysing the dimensions tolerance gap associated with Medical Devices mating parts.•Working for Medical devices Tolerance Stack up Analysis, Cad Designing of 2d and 3d Components, Mechanical Drawing redline activities.*Integra_MDR :*MDR update for labels and IFU.*Project 2:**Siemens Healthineers_IVDR* For In-vitro Diagnostic Devices IVDR Regulations updates.*Project 1:**Baxter_MDR :*•Worked in Gap Assessment of Medical Devices documents with reference to ISO 13485 - MQMS MEDICAL QUALITY MANAGEMENT SYSTEM, ISO 14971-Risk Management, ISO 15223-Labelling Requirements, ISO 10993-Biocompatibility Assessment, ISO 60601 - Electromechanical symbols.•MDR Gap Assessment - Comparing IFU and Labels with respect to the latest Medical Devices Regulations and identifying the gaps that are associated.*Baxter_BOM:*• Creation of Bill of Material BOM for Medical Devices.• Parent Code and Child Code mapping activity.*Baxter_Specification:*•Creating Document ID for various Medical Devices Documents.•Uploading Medical Devices in PLM Team Centre TcU for respective item ID.*Baxter_Abiogenesis:* • Handling various Medical Devices Documents such as DHF (Design History File) & DMR.•Gone through Design Input, Design Output, Verification and Validation documents.