Prepare and update post market surveillance plan (PMSP), related activities & post market surveillance report (PMSR / PSUR) for medical devices (combination products).Assessment of public reporting health authority safety databases for post-market surveillance. Coordinate the PMS data quarterly reviews and document the meeting minutes.Communicate the quarterly review recommendations to Management Representatives during Management Review.Collect, analyses and present data using appropriate visualization tool (e.g. Tableau, Power BI and Qlik Sense) to support report preparation.

Working as a CAD Engineer, Performed CCM (Change Control Management), DMR & DHF File Indexing, BOM Structure Creation, Specification Standardization, Design History File Remediation and Design Verification & validation, Value Analysis and Test Method Validation and Value Engineering. Job Responsibilities and Accomplishments● Design Parameter Activity: Executing assigned work requests pertaining to creation of drawings, models and low level designs through various tools like Creo, Catia V5, Ansys, Fluent etc. as per the client requirements within stipulated timelines. To create new designs and models or redo the existing model for meeting client’s prescribed standards for New Product Development (NPD).● Working on BOM structuring, Design Parameter Input analysis, manually review and validate the generated outputs; maintain relevant documentation in client database.● Team Center Unified Migration: Migrating DHF, DMR files from customer’s drive to Team Center Unified using scripts. High level knowledge and experience on TcU (Team Center Unified): My Team Centre, Structural Management, Workflow designer, etc.● DHF Remediation: Remediate the DHF files like plan document, Labelling documents, system and sub system documents, FMEA documents, etc.● CCM: Experience with Engineering Change Control (ECN/ECO Process) using Track Wise Tool.Responsibility of the Internal Quality Audit (IQA) and Various Project Management tools.● Test Method Validation: Performed Test Method Validation (variable study) on inspection equipment’s (Video Measuring System) with Gauge R&R using Minitab 16, DFA/FMEA on NPDs.● Quality Activity: Six Sigma Green Belt Holder, Responsibility of the Internal Quality Audit (IQA).