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Skills:
Design History File Compilation, Technical File Documentation, Design Verification, Quality Tools, usability engineering, Statistical Methods, Risk Management, Post Market Surveillance, ISO 13485 Quality Standard, Complaint Investigation, MDD, IEC EN 62366, 21 CFR 4 Regulation of Combination Products, Quality Risk Management, Process Qualification and Validation, Corrective Action and Preventive Action System, MDR, Test Procedure Development, Design Control Activities, ANSI HE75 Human Factors Engineering
Skills:
Statistical Analysis, Switching power supplies, 3D electromagnetic modeling tools, Circuits, electromagnetics
