Job Summary: The NPD Engineer II position is focused on polymer and material science and is responsible for providing technical expertise, leadership and planning to smaller projects. The NPD Engineer II is typically a technical team member. The NPD Engineer II - Design Engineer position is specifically accountable for the product design, development, and technical problem solving. This position executes the Design for Excellence (DFX) aspect of the processes and product design. Job Details Perform the design, development, and qualification of products and processes. This may include feasibility studies, designing & implementing evaluations (DOE's) and providing technical input for justification of project and design. Responsible for contributing to the DHF and regulatory submittals, creating SOP's, and for providing training to ensure proper design transfer. Implement projects to design, develop, and qualify new processes for manufacturing new products or improving existing products / processes. Perform as a Technical team member on a large project to develop and implement the technical aspects involving design, prototype fabrication and/or testing. Develop and execute projects in accordance with Terumo new product development process in full compliance with all design control, quality, and company regulations and national and international regulatory body requirements. This activity includes, but is not limited to, the understanding of change control, validation, documentation practices, process control and design control requirements. Contribute to project performance team meetings on behalf of the project technical team in order to provide ideas, methods, or designs for performance improvement. Prepare & lead small technical design reviews to a cross-functional and technical team. Prepare and present product designs, production processes and related activities to management. Communicate with various levels in other sections within Terumo for related projects or progress (ie daily interactions with managers, supervisors, NPD engineers and technicians, production personnel, purchasing, logistics, etc ). Implement product performance and design basic strategies. Define and write test plans/protocols, perform testing, analyze results, suggest recommendations and/or conclusions and document clearly and completely in technical reports. These reports could be to support product development prototype evaluations, or could be submitted to the FDA to support new product clearance or claims. Possess a thorough theoretical and practical understanding of design control requirements, both from a regulatory body' perspective and within Terumo's systems. Possess ability to implement design control requirements in an effective, efficient, and compliant manner. Ability to train and lead colleagues in the interpretation and implementation of design control activities. Performs other job related duties assigned. Background Experience - BS in Material Science, Chemical Engineering, Polymer Engineering, or Plastics. Demonstrated successful execution of a project including development and documentation. Demonstrated experience implementing strategies for product design and development based on customer needs and Design Input. Demonstrated design and comparative analysis skills. Demonstrated successful decision making skills. Experience with performing comparative analyses and making a recommendation. Demonstrated analytical and logical problem solving abilities. Strong troubleshooting skills for solving process and design issues during product development. Demonstrated ability to distill complex technical information and explain to a much less technical audience. Experience in presenting and explaining to management. (verbal communication) Demonstrated strong technical writing and presentation skills. (written communication)