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Nihon Kohden OrangeMed, LLC

Senior Mechanical Design Lead - Medical Devices

northern, KY

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About this opportunity

Nihon Kohden OrangeMed, LLC lists this Senior Mechanical Design Lead - Medical Devices opportunity in northern, Kentucky. Review the employer’s description below for duties, qualifications and application requirements.

Job description

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

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