IZiel Healthcare
Logan Mayer is a seasoned professional in quality engineering with extensive experience across various sectors, including aerospace, defense, and medical devices. Currently serving as a Sr Manufacturing Quality Engineer at IZiel Healthcare since May 2022, Logan has held positions such as NPI Quality Engineer at Orchid Orthopedic Solutions and NPI Quality & Supplier Quality Engineer at Phillips-Medisize. Previous roles include Quality Engineer at Curtiss-Wright Corporation, Stellar Microelectronics, Donaldson, Glenair, and Natel Engineering Co., Inc., where Logan focused on quality assurance, failure analysis, and internal auditing. Education includes a Bachelor of Science in Electrical Engineering from Worcester Polytechnic Institute and ongoing studies towards a Master of Education in Materials Engineering at California Polytechnic State University-San Luis Obispo.
This person is not in any offices
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