Vishnu K.

Qualified Mechanical Engineer with both creative & structured approach. I have 3 years of professional experience in the field of NPD of medical devices. Executed Mechanical Engineering role on sustenance engineering/DHF updated projects to execute product sustenance deliverables. Competent in designing & developing new concepts and good hold on engineering design, 3D CAD modelling, 2D drafting, surface and sheet metal module on SolidWorks. Also have experience in CAE (static structural analysis and thermal analysis) on ANSYS. Experienced in updating design transfer & QMS documents, CAD drawings. Familiar with design controls per FDA Regulation 21 CFR part 11, ISO 13485, ISO 14971, ISO 27001, EU MDR, etc,. for medical device industry product.