Description Responsibilities • Lead mechanical design and development of medical device components, mechanisms, and assemblies. • Own product development from concept through commercialization, including requirements, design, prototyping, verification, and manufacturing transfer. • Design robust, manufacturable solutions using appropriate materials, processes, tolerances, and cost considerations. • Conduct risk management activities, including design reviews and FMEA, to ensure compliance with applicable regulations and standards. • Create and maintain engineering documentation, including CAD models, drawings, and Design History Files (DHFs). • Collaborate with electrical, software, quality, manufacturing, and regulatory teams to deliver integrated products. • Mentor and provide technical guidance to junior engineers. • Stay current on medical device technologies, regulations, and industry best practices. Requirements Qualifications • B.S. or M.S. in Mechanical Engineering or a related field. • 7–10 years of product development experience, including at least 5 years in medical devices or other regulated industries. • Demonstrated experience bringing products from concept to market. • Proficiency in 3D CAD (e.g., SolidWorks) and PDM systems. • Strong knowledge of DFM/DFA, GD&T, and mechanical systemdesign. • Experience with mechanisms and mechanical analysis. • Familiarity with verification testing, reliability engineering, and human factors considerations. • Excellent problem-solving, communication, and technical leadership skills. • Ability to work independently and lead cross-functional design efforts. Preferred Experience • Class II or Class III medical devices. • Fluidics, micro-mechanisms, or disposable device design. • Hands-on prototyping and test fixture development. • Exposure to project management tools and agile development methodologies.