We are seeking an experienced Senior Mechanical Engineer to join an innovative medical device organization specializing in diagnostic technologies. This hands-on role offers the opportunity to work across the full product lifecycle, from concept and design through testing, manufacturing, and commercialization. The ideal candidate is a creative problem solver with strong mechanical design expertise and experience developing complex medical devices. Requirements of the Senior Mechanical Engineer: Bachelor's degree in Mechanical Engineering or a related engineering discipline.8–15 years of relevant mechanical engineering experience, preferably within the medical device industry. Proficiency in SolidWorks CAD software, including mechanical component and assembly design. Experience working with biocompatible materials, adhesives, and material processing techniques. Strong background in engineering mechanics, electromechanical design, and manufacturing processes. Experience designing production fixtures and supporting manufacturing process improvements. Excellent analytical, troubleshooting, technical documentation, and cross-functional communication skills. Knowledge of FDA, ISO, CE Mark, and EU MDR requirements preferred; experience with circuit design, flexible circuits, or miniature components is a plus. Responsibilities of the Senior Mechanical Engineer: Design, develop, and document mechanical components and systems for advanced medical diagnostic devices. Provide engineering support for existing products, troubleshooting complex manufacturing and production challenges. Develop and optimize product designs, manufacturing processes, and production fixtures to improve performance, reliability, and manufacturability. Create and execute test plans to evaluate product functionality, performance, and compliance with specifications. Research and evaluate new materials, technologies, and manufacturing processes to enhance product quality and reduce costs. Lead failure investigations, identify root causes, and implement corrective actions to improve product reliability. Support product verification, validation, and regulatory compliance activities in accordance with FDA, ISO, and EU MDR requirements. Collaborate with cross-functional teams and external suppliers to resolve technical challenges, maintain engineering documentation, and support product commercialization.
