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  1. Abstract Insufficient engineering analysis is a common weakness of student capstone design projects. Efforts made earlier in a curriculum to introduce analysis techniques should improve student confidence in applying these important skills toward design. To address student shortcomings in design, we implemented a new design project assignment for second-year undergraduate biomedical engineering students. The project involves the iterative design of a fracture fixation plate and is part of a broader effort to integrate relevant hands-on projects throughout our curriculum. Students are tasked with (1) using computer-aided design (CAD) software to make design changes to a fixation plate, (2) creating and executing finite element models to assess performance after each change, (3) iterating through three design changes, and (4) performing mechanical testing of the final device to verify model results. Quantitative and qualitative methods were used to assess student knowledge, confidence, and achievement in design. Students exhibited design knowledge gains and cognizance of prior coursework knowledge integration into their designs. Further, students self-reported confidence gains in approaching design, working with hardware and software, and communicating results. Finally, student self-assessments exceeded instructor assessment of student design reports, indicating that students have significant room for growth as they progress through the curriculum. Beyondmore »the gains observed in design knowledge, confidence, and achievement, the fracture fixation project described here builds student experience with CAD, finite element analysis, 3D printing, mechanical testing, and design communication. These skills contribute to the growing toolbox that students ultimately bring to capstone design.« less