System Engineer

Title: Systems EngineerLocation: St Louis, MOJob Description:Read, understand, and interpret applicable industry standards and government regulations.Distill testable requirements from partial to complete designs and SME knowledge.Perform risk analysis at component and system levels and generate relevant design mitigations.Assist in test development for the system, surgical functions, and accessories.Respond to integration & test issues with the best plans for rapid correction.Adjust drafted requirements for subsystems of medical devices. Determine strategy and needs for life testing, and reliability testing necessary to hit design goals.Use Aras PLM to create traceability between design inputs, design outputs, design documentation, regulatory standards, risk items, mitigations, and architecture.Education & Qualification:BS in Engineering (Systems, Biomedical, Electrical, Mechanical)7+ years’ experience as an engineerProven track record of launching complex electro-mechanical systems with a high regulatory burden.Experience with risk analysis, requirement management, and verification planning. Excellent communication & organizational skills.Skills:Successfully launched a surgical medical deviceDeep familiarity with the relevant regulations and industry standards (FDA, MDR, CA, UKCA, ISO, IEC, ETSI, etc...).Experience using Aras PLMFamiliarity with medical device labeling