Amitesh Kumar

Background

About Amitesh Kumar

Having 15 years of experience as a Design and Development engineer of Medical devices and diagnostics domain for NPI and sustaining products • Hands-on experience in creating lower-level requirements from the system requirements • Good understanding of medical device standards (ISO 13485, ISO 14971, 21 CFR 820, EU MDR, 21 CFR 820, IEC 60601, IEC62304 & IEC62366). • Good in Sustenance engineering activities & Engineering Change Order (Change Request to Change Order Completion). • Good understanding of Verification & Validation activities. • Hands-on experience in handling CAPA • Reasonable experience in Risk Management Activities • Expert in designing the product using CREO 6.0 • Excellent communication and interpersonal skills • Quickly adapted to the implementation of a new tool, leveraging my technological acumen to train team members on its use and improve overall project coordination and communication.