12+ years of experience in Digital Engineering & Product Development, Quality and Regulatory Compliance, and End-to-End Product Lifecycle Management areas
8+ years of experience implementing PLM, QMS and RIMS related capabilities for Healthcare / Medical Devices companies
Good understanding of leading PLM, QMS and RIMS software platforms such as Siemens, Dassault Systemes, PTC, Oracle & SAP
Good implementation experience of at least two of the leading software platforms
Proven ability to develop current state process mapping, target state process definition, and business and functional requirements specifications
Proven functional knowledge in the following process areas: - Document Management - Device History File (DHF) Management - Change Management - Part Management - Engineering & Manufacturing Bill of Materials Management - CAPA - Non-Conformance Reporting - Device Master Record (DMR) Management - Integrations between Teamcenter PLM and CAD applications; PLM-ERP; and PLM-MES