· Participate in product development including concept, generation, decision matrices, prototype, manufacture, and associated metrics
· Provide detailed design and development output for the development projects assigned; this includes unrelenting attention to minimizing project delays and resource overages
· Creates product designs and documentation used to substantiate those devices (i.e. risk assessments, verification/validation activities, design review documentation, etc.)
· Develops detailed engineering drawings using 3-D Modeling to document designs and design changes (SolidWorks)
· Confers with cross-functional team to identify tasks and requirements (Product Development, Manufacturing Engineers, Quality Engineers, Marketing, Purchasing and Regulatory Affairs)
· Maintains all documentation necessary for a Design History File (DHF), including Design Input Documents, Design Validation Plans/Reports, Test Protocols/Reports, and Design Input/Output Matrix.
· Assist in the 510(k) application process by providing official information for FDA review