Mechanical Engineer

Lead mechanical design and development of medical device products from concept through launch in a highly regulated, design-controlled environment. Translate product and system requirements into innovative design solutions; develop detailed 3D models, drawings, and specifications using SolidWorks; perform tolerance stack-ups, GD&T, and statistical analyses to ensure performance. Support design control activities including DFMEA, risk analysis, and documentation; conduct and support testing activities including engineering confidence testing (ECT) and validation efforts; perform FEA and other analyses to validate design performance and safety. Apply DFM/DFA principles to optimize manufacturability and assembly; collaborate with vendors to prototype, test, and refine designs; lead design reviews and drive continuous improvement of existing products; investigate materials, processes, and design enhancements to improve performance and reliability; perform root cause analysis and implement design changes as needed. Own the product development lifecycle from concept to commercialization in a highly collaborative environment with engineering, quality, and manufacturing teams; exposure to cutting-edge medical technologies and applications; opportunity to influence both new product development and continuous improvement efforts.