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. Proven expertise in implementing and maintaining Quality Management Systems (QMS) to enhance overall operational efficiency. Played a key role in the successful completion of regulatory audits (ISO 13485), demonstrating compliance with industry standards and regulations. Demonstrated success in conducting thorough testing, identifying defects, and implementing corrective actions to deliver high-quality products. Gained deep expertise and knowledge while working for the defence, medical and automotive industries. I have a deep knowledge of FDA regulations, IVD, ISO 13485, ISO 14971, and ISO 27001 standards for medical device validation as well as AAMI TIR-45 Agile in Medical Device Development. With the knowledge of Agile methodology, I thrive in dynamic project environments and excel in driving teams towards successful project completion. I am adept at effectively managing timelines, resources, and stakeholders to achieve project objectives while maintaining the highest quality standards.