Masters degree in Biomedical Engineering, Electrical Engineering, Mechanical Engineering or in a closely related field required with an academic or industrial background in i evaluating and documenting compliance and essential requirements; ii completing verification activities and reports utilizing experience in Product Lifecycle Management PLM documentation systems; iii coordinating the completion and timing for execution of design related project deliverables such as design assessment by partnering with crossfunctional teams; iv system engineering principles, risk management, system configuration, system verification, use case development, requirements management, configuration management, and issue tracking tools; v performing evaluation on customer complaints of reported issues against the established device risk profiles; vi knowledge of product lifecycle from initial design to obsolescence; vii medical devices with integrated mechanical, electrical, and software components and related ISO standards and requirements, including FDA 21 CFR 820, ISO 14971, and ISO 13485; viii using oscilloscopes, signal generators, spectrum analyzers, and voltmeters; and ix multicomponent electrical devices, PC interfaces, communication protocols, digital design, DSP, and wired and wireless communications.
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