Must possess a Masters degree in Mechanical, Industrial, Biomedical or Electronics Engineering and two 2 years of experience in RD engineering or Manufacturing Engineering.br br Must possess a minimum of two 2 years of experience with each of the followingbr br Product Design, Process Development and Manufacturing and Quality control of Class II and Class III medical devices;br FDA QSR, CFR 820, ISO13485, ISO14971 and EU Medical Device Directive;br Risk analysis activities including health hazard assessment, Fault Tree Analysis, Process Failure Mode Control Analysis, Design Failure Mode Control Analysis and CAPA;br Analyzing Postmarket surveillance, investigating and responding to complaints;br Measurement System Analysis, Design of Experiments and Statistical Process Control, Process Capability and Sampling Techniques;br Development of Installation Qualification IQ, Operation Qualification OQ, Performance Qualification PQ, Gage RR and Test Method validations TMV; andbr Good Manufacturing Practices GMP and Good Documentation Practices GDP.

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