Risk Manager
Stefanini Group is hiring!
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The resource shall act as subject matter expert to assist functional owners of elements of the risk management file with planning and updates.
Essential Duties & Responsibilities:Demonstrated ability to communicate with a wide set of stakeholders (Quality, Systems/Risk, PM, RA, Marketing, etc.).Demonstrated understanding of the end-to-end process of identifying stakeholder needs, translation to Design Inputs and tracing these to the Design Outputs.Demonstrated understanding of operational, functional & physical architectures & their use for analyzing hazardous situations.Demonstrated understanding of Systems Engineering driven process for achieving ISO 14971 compliance.All work shall be performed in accordance with the company’s policies and procedures for design control and risk management.
Qualifications:Master’s in systems engineeringFormal systems engineering environmentINCOSE Certified – preferredMedical device experience (Quality Management System) – nice to have10 plus years of experienceSoftware development is a plusSoftware/Electrical Engineering development is a plus