Position Summary: The Principal Tooling/Vision Engineer is a "hands-on" position that plans, directs, and coordinates manufacturing equipment and processes to produce high quality injection/blow molded plastic product. + Responsible for coordinating the molding efforts on new program launches, setting up and/or revising manufacturing processes and assisting the manufacturing operations in problem solving and continuous process improvements. + While monitoring the effectiveness of processes this individual quantifies results, documents, and presents findings to management and prepares reports. + This position also mentors and provides training to other injection/blow molding personnel. Primary Responsibilities: Function as a Plastics/Vision Subject Matter Expert (SME) to assist with the development, production, and maintenance of plastic parts: + Troubleshoot problems with existing parts by determining root cause and resolving issues from non-conforming materials. Take immediate actions as needed to improve quality and keep production going. + Assist as needed with Change Requests, First Article Inspections, Validation/Verification of new parts and changes following our policies and processes around quality control. + Travel as needed to work with vendors. + Develop and implement machine vision systems utilized to measure various plastic part parameters. + Specify machine vision components, acquire quotes, and facilitate purchase justifications. + Specify lighting, controllers, lenses, and filters as needed for the machine vision systems. + Design machine vision mounts, supervise fabrication and installation of the machine vision mounts. + Systems shall include image acquisition and processing. + System shall be able to provide pattern recognition. + Maintain various machine vision software applications. + Assist suppliers with drafting quality protocols and overseeing their execution including use of reject artifacts to challenge and verify the machine vision system’s reject detection and rejection mechanisms. + Develop and deploy a relevant operator interface that will facilitate: + Table of inspection results, Pass/Fail counters for each rejectable attribute. + Manual inspection results counter reset function by maintenance technicians. + Analyze and interpret data collected from vision systems that are specific to the tooling applications. Namely, develop a time-stamped record for each inspection variable and attribute data, such as a .csv file with a one row per inspection data recording method or some other approved database method. + Ability to train and support others in the use of the vision systems. This must include remote login capability in order to support machine vision systems remotely. + Create a means to consistently reject bad parts and approve good parts. Minimize false rejects. + Monitor and report issues with injection/blow molds and make recommendations for refurbishment based on production factors such as cycles, process capability and tooling history. + Develop new processes, assess, and document new and existing processes. Implement and evaluate changes to existing processes designed to improve product quality, productivity, and overall equipment efficiency. + Implement technical solutions including statistical methodology to meet customer cost, quality, and delivery expectations. + Use Lean Manufacturing, Six Sigma, and other techniques to analyze process data to determine capabilities as well as improvement. + Provide technical leadership and mentorship to process technicians, operators, and other molding personnel. Education, Skills, & Experience: + Bachelors degree in Engineering or Material Science with 10 years of experience in vision OR + An Associates degree with 15 years of experience in vision system OR + In lieu of a degree, high school diploma/GED with 20 years of experience in vision system + Designing, building, maintaining, troubleshooting machine vision systems. + Familiar with a wide range of molding processes including injection molding, blow molding, structural foam, compression molding, vacuum forming, etc. + Experience with tooling systems preferred but not required + Working in a regulated industry (design control), preferably FDA project management. + Able to travel in the 75% range. Most travel will be drivable from the Raliegh/Durham area. + Knowledge of statistical methods is a plus. + Able to prioritize projects and multitask between multiple projects in parallel. #LI-US #biojobs