This is a “hands on” engineering position responsible for leading the development, installation, validation, ramp-up, and life cycle management of injection molds and molding solutions for medical device components.Responsibilities:Serve as a Subject Matter Expert (SME) for injection molding systems.Develop a robust and repeatable process window based on scientific process engineering principles.Implement statistical process analysis on new and existing moldsDocument all injection molding system set-up requirements in Process Information Books and one-point lessons.Trouble shoot process related issues through a structured DOESupport the development of new injection molds by participating in mold design reviews and mold factory acceptance trials.Support the production ramp-up phase for new products and train appropriate personnel as needed.Lead Factory Acceptance Testing (FAT) at domestic and European mold vendors.Track process performance metrics and manage ramp-up action plan to achieve operational performance targets.Manage multiple programs with continuous collaboration with the project teams.Investigate and benchmark new tooling, peripherals, and molding technologies.Contribute to the development of specifications for the procurement of new injection molding machines and auxiliaries.Perform the initial set-up and establish the standards for injection molding systems.Implement safety, productivity, and yield improvementsProvide continuous development of manufacturing techniques that will improve in-house capabilities.Participate with root cause investigations and corrective action implementation.Support lean and continuous improvement initiatives.Follow all safety procedures including the use of Personal Protective Equipment as required.Maintain good housekeeping of both office and factory workspaces.Work in ISO7 and ISO8 controlled environments with cGMP gowning requirements.Preferred/Required Education/Skills:Engineering, technical degree or equivalent preferredRJG Master Molder I Certification strongly preferredProcess Engineering experience working in high-volume plastic injection moldingIndustrial manufacturing experience working in high-volume injection moldingExperience in the qualification of complex, tight tolerance injection molds (2-shot + Cube mold technologies)Must have clear and well organized oral and written communicationKnowledge of statistical methods & statistical software (6 Sigma, SPC, DoE, Minitab)Excellent problem solving skills using DMAIC methodologyExperience working in a cGMP / ISO 13485 compliant manufacturing environmentOccasional travel up to 15 percent based on assignments; domestic and internationalAbility to lift 55lbs 
