Requires Masters or foreign degree equivalent in Mechanical Engineering, Biomedical Engineering, Biomedical Innovation Development, or related field plus 3 years of related experience. Requires 3 years of experience with design control processes for medical devices and clinical application of surgical instruments; verification and validation studies; medical device regulations, including design and development procedures and FDA 21 CFR820 regulations; Agile Change Control and SAP; quantitative process development, including pFMEA, tolerance analysis, DoE, SPC, GRR, and CpK; CAD engineering design and drafting using SolidWorks, Abaqus, Ansys, and GDT; and risk analysis and management, including FMEA, Hazard Analysis, and ISO 13485.
Categories: eb3
0 Comments