Developed and conducted failure analysis tests on returned medical devices to determine root cause of failures that occurred in clinical settingsCollaborated with design partners to target product improvement initiatives to reduce occurrence of failuresLed a team of engineers on a wide variety of products to conduct failure analysisBecame a subject matter expert on risk documentation and manufacturing records to produce accurate investigation results that included crucial references to design and manufacturing quality recordsLed signal evaluation meetings to determine need for and facilitate resourcing on escalations based on complaint data monthlyParticipated in audits with regulators such as FDA, BSI, DEKRA to provide data and investigation results to support satisfactory audit results with no findings on the complaint investigation site. Documented results within a quality system to keep accurate and auditable records of all activities

Led a multidisciplinary team through design reviews, leading to customer approval of major project milestonesManaged interdisciplinary team during the design phase of the system, culminating with the construction and test of a prototype development unit through satisfactory functional qualification testsResponsible for configuration management of all work products related to the system, including specifications, white papers, process plans, and design history notebooksReported progress on all activities to management to ensure work is completed on schedule and budgetEstablished project processes, formalized a system development plan that documented standard practices used during the development of the system. This included the creation of a project schedule and budget