Description: Provide a qualified resource to assist client in supporting risk management activities for the Front Line Care Patient Monitoring Portfolio. The resource shall act as subject matter expert to assist functional owners of elements of the risk management file with planning and updates. 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 Client policies and procedures for design control and risk management. Masters 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 Notes: 7am-6pm CST (flexible)VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status
Description:
Provide a qualified resource to assist client in supporting risk management activities for the Front Line Care Patient Monitoring Portfolio. The resource shall act as subject matter expert to assist functional owners of elements of the risk management file with planning and updates. 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 Client policies and procedures for design control and risk management.
Masters in Systems Engineering
Formal systems engineering environment
INCOSE Certified - preferred
Medical device experience (Quality Management System) - nice to have
10 plus years of experience
Software development is a plus
Software/Electrical Engineering development is a plus
Notes:
7am-6pm CST (flexible)
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