Senior Mechanical Design Lead - Medical Devices

Nihon Kohden Orange Med is seeking a Mechanical Design Engineering Manager to lead, develop, and direct the mechanical engineering team within the R&D organization, overseeing the design, development, validation, and lifecycle management of medical device products. The role requires strong leadership, extensive CAD experience (SolidWorks), and deep knowledge of FDA Design Controls, ISO 13485, IEC standards, and regulatory submissions for Class II and III devices, delivering high-quality