IZiel Healthcare
Ankur Naik has extensive work experience in the healthcare industry and engineering field. Ankur is currently the Managing Director at IZiel Healthcare and also serves as a Partner and Chief Technology Officer at IntegriMedical Pvt Ltd. Previously, they held senior program management positions at Boston Scientific, where they were responsible for product design and development, process validation, and managing product remediation. Prior to this, they were a Senior Program Manager at American Medical Systems, which was later acquired by Boston Scientific Corporation. Earlier in their career, Ankur worked at Medtronic as an Engineering Program Manager and Principal Mechanical Design Engineer, specializing in Design for Six Sigma and voice of the customer analysis. Ankur also worked as a Design Engineer at Tata Technologies, managing the design of heavy commercial vehicles and coordinating cross-functional teams. Before entering the industry, Ankur gained teaching experience as a Graduate Teaching Assistant at Wayne State University, where they taught mechanical engineering design and problem-solving.
Ankur Naik holds a Master's degree in Business Administration from St. Cloud State University - Herberger Business School, which was earned between 2010 and 2012. Prior to this, they obtained a Master of Science degree in Mechanical Engineering from Wayne State University from 2003 to 2005. Ankur completed their Bachelor's degree in Mechanical Engineering from Maharashtra Institute of Technology from 1998 to 2001. Ankur also holds a Diploma in Mechanical Engineering from K J Somaiya Polytechnic, which was obtained from 1995 to 1998. Additionally, they have obtained the Project Management Professional certification from the Project Management Institute in 2007.
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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