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Responsibilities Performs full equipment and mold validations to insure budgeted cost and quality levels are achieved. Prepares required documentation i.e., validation protocols/reports to meet quality system guidelines. Develops and performs of DOE’s as required per the business needs. Collect and statistically analyzes data, and document results in process development, IQ, OQ, and PQ completion reports. Assists supervisors and molding technicians to improve quality and output of molded components. Coordinates and performs hands on trouble shooting on molding issues with the tool/machine maintenance group. Supervises operating parameters of molds and related support equipment. Assures adherence to manufacturing tolerances. Directs the molding technicians in setting optimum molding parameters to achieve production volume goals at the lowest cost. Issues periodic status reports on molds and other related equipment. Coordinates with other Engineers and Manufacturing Process Technologies (R & D) to improve existing plastic parts and generates appropriate support data to gain approval for recommended changes. Makes recommendations as to the technical feasibility of the method or means to resolve diagnosed problems. Coordinates new molding projects. Qualifications Bachelor’s Degree (B.A.) in mechanical engineering or plastics related degree 3 to 5 years of experience in plastics molding, including validation and product development for a medical device manufacturer. Understanding of tool design, troubleshooting, and component qualification RJG Systematic molding training or scientific molding related certification ISO 13485:2012 regulations #J-18808-Ljbffr