Manager Systems Engineering - Molecular Diagnostics
Will be responsible for systems engineering and analysis in the research, engineering, design, manufacturing and testing of new molecular diagnostic tests in the Molecular Diagnostics Unit of Novartis Pharma. Will drive activities and provide guidance as necessary to members of the Systems group in the development of diagnostic tests in the MDx unit. Responsible for assuring molecular diagnostic tests meet product requirements, applicable standards (FDA). Apply best practices (Design for Six Sigma or DFSS) to test development across the MDx Unit. Develop the Company's know-how in molecular diagnostic tests. Evaluation of new technologies for molecular diagnostic testing (some overseas travel required).
Requirements:
BS/MS in Engineering (Biomedical/ Bioengineering, Mechanical, Electronic, Chemical, Systems) with minimum of 7 years experience in Life sciences or medical device development.
In-vitro molecular diagnostics experience essential. Familiar with regulatory and compliance requirements for diagnostic tests. Experience in engineering design, optics, hardware, system architecture, application support, and disposables. Minimum 2 years in role as systems engineer or system analyst. Experience working on multi-disciplinary projects. Strong knowledge of assay chemistry for diagnostic tests/molecular biology.
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