Requires a Bachelors degree or foreign equivalent in Mechanical, Industrial, Biomedical or Electronic Engineering and four 4 years of experience in manufacturing engineering for medical devices.br br Must possess a minimum of four 4 years of experience with each of the followingbr br Development and optimization of products to include laser cutting, electropolishing, processes, tooling, and equipment;br FDA QSR Quality System Regulation 21 CFR part 11;br Developing processes to optimize animal tissue;br Good Manufacturing Practices GMP and Good Documentation practices;br Process and DFMEA design failure mode effective analysis and root cause analysis;br DOE Design of Experimentsbr Installation Qualification IQ, Operation Qualification OQ, Performance Qualification PQ, Gage RR and Test Method validations TMV;br DMAIC, Six Sigma, CAPA Corrective and Preventative Action and NCMR NonConformance Material Request;br CAD ComputerAided Design Tools SolidWorks and ProECREO.

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