Process Development Engineer I

Responsible for process identification, parameter optimization, proof of concept testing, technology improvements, and process implementation. Responsible for tool, extrusion, and fixture design and qualification used for manufacturing medical devices and components. Must be able to accomplish broad and complex assignments. Capable of providing technical guidance to lower level personnel. Responsible for developing processing parameters for medical devices and components. Responsible for screening and optimization of process parameters to maximize yields, efficiencies and process capabilities. Plans and conducts work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria. Design and perform Process Characterization Study’s & DOE’s, support protocols and reports. Have a firm understanding of validation strategy (IQ/OQ/PQ), support protocols and reports. Independently performs most assignments with instructions as to the general results expected. Perform data analysis to determine product performance and capability. Responsible for generating Work Instruction, Workmanship Standards, Engineering Memos and other related documents. Understand and execute Test Methods as well as develop inspection techniques for devices or components that cannot be measured using traditional methods. Works on problems and projects of moderate scope where analysis of situation or data requires a review of identifiable factors. Selects techniques to solve complex problems and make sound design recommendations. Exercises judgment within defined procedures and practices to determine appropriate action. Demonstrates full use and application of standard principles, theories, concepts and techniques. Selects design direction or modifications of components of systems. Work with project managers to create a project plan and timeline. Receives technical guidance on unusual or complex problems and supervisory approval on proposed plans for projects. Plans, schedules, conduct, and coordinates detailed phases of engineering work in part of a major project or in a total project of moderate scope. Performs work that involves conventional engineering practice but may include a variety of complex features such as conflic