IZiel Healthcare
Gaurav Mahajan is a skilled engineer with extensive experience in process engineering and manufacturing. Currently serving as a Sr. Process Engineer at IZiel Healthcare since October 2021, Gaurav previously held the position of Manufacturing Engineer at Zimmer Biomet from May 2019 to July 2021, where responsibilities included updating work instructions and implementing changes to ensure compliance with GMP/GDP standards. Gaurav began the career as a Quality Control Intern at Chasis And Brakes International and also completed an engineering internship at RATHI TRANSPOWER PRIVATE LIMITED. Gaurav holds a Master of Science in Industrial Engineering from The University of Texas at Arlington and a Bachelor of Engineering in Mechanical Engineering from MCT's Rajiv Gandhi Institute Of Technology.
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IZiel Healthcare
IZiel Healthcare is an Engineering & Regulatory Services provider working successfully for global medical device manufacturers from our offices in USA & India. Our engineers are trained as per Design for Six Sigma – Black Belt Level and have completed various projects in Design, Process Validation, QMS Documentation, Regulatory Approvals & Acquisition Integration for Class I, IIa, IIb & III Products. We leverage statistical & data-driven methods, domain knowledge & robust work planning methodology to achieve an optimized product development processes for guaranteed success. IZiel Healthcare provides services in: Design - Systems Engineering and Requirements Management - Transfer Function Development - Predictive Engineering - 3D Modelling & Finite Element Analysis (FEA) - Design Controls Process & Software Validation - PVMP - IQ, OQ, PQ - Test Method Validation (TMV) - Productivity Improvement - Software Validation (IEC 62304) Risk Management - ISO 14971 based Risk Management - FMEA and FTA Based Product Risk Analysis - Quantitative Risk Management Expertise Quality Management Systems and CAPA - QMS Documentation with Procedures & Templates - CAPA (Corrective & Preventive Action) Regulatory - USFDA & CE Approvals - MDD – MDR Conversion - Clinical Evaluation Report (CER) - European Authorised Representative (EAR) Remediation - Resolve Observations (Form 483), Warning Letters etc - Product Remediation Training - Training – DFSS Methodologies and Engineering Topics