Principal R&D Engineer

Job Summary For Principal R&D Engineer Lead the design, development, and refinement of complex neurovascular catheter devices. Drive experimental validation activities to ensure device performance, functionality, and reliability. Develop, test, and iterate device prototypes throughout the product development lifecycle. Prepare and maintain design control documentation to comply with medical device regulations and quality systems. Collaborate with cross-functional teams (engineering, quality, manufacturing, regulatory) to ensure products meet technical, regulatory, and customer requirements. Support and execute design verification and validation activities. Apply engineering principles to solve complex product and design challenges. Support CAPA (Corrective and Preventive Action) activities related to product and design issues. Provide technical guidance, mentorship, and support to junior engineers. Work with manufacturing teams on device materials, processes, and manufacturability, especially in metal braiding, laser cutting, polymer extrusion, and injection molding. Contribute to product development and design improvement initiatives. Ensure adherence to quality standards, including design controls, 21 CFR 820, and other medical device regulatory requirements. Communicate technical concepts effectively and prepare technical documentation as required.