This document outlines the author's experience and knowledge stack spanning over 12 years working in healthcare, medical devices, and IT systems. They have experience in medical device product planning, FDA and regulatory processes, enterprise architecture, remote patient monitoring, and project management. Their technical skills include programming in C/C++, assembly language, and DSP for healthcare and industrial automation applications.

1. My Experience/ Knowledge stack
Year 12+
Medical Device Product
IT system Proposal
Planning, Go to Market
Development,
Development
Strategy, NPI, Product
Account Growth
rollout management,
Healthcare Business
Healthcare Enterprise Architecting, Cardiac Process
Disease management & Remote patient Management
monitoring
IT Program / Account management, Onsite
Migrated to USA Year 7+ Offshore Project estimation, FPP – T&M models, FDA 510k process,
Maintenance model, Contract & Alliance IEC 62304, ISO
Management 13485 & 21CFR 820
Project Management, Delivery Quality,
Project Management Delivery Quality
Performance Metrics management, Goal setting
Sixsigma Black belt
for team & Appraisal evaluation
MS Software systems Year 3+ Medical Device, Healthcare Requirement Medical device
development, Project Estimation, Module level Manufacturing,
management Production planning,
Production planning
material
C/ C++, Assembly Language & DSP programming management, ERP
in Healthcare and Industrial Automation implementation
BE Electrical & Electronics Year 1+
Technology Management Functional Knowledge