Associate Project Engineer
Current• Gather market feedback to define functional and design specifications and create and maintain project Plans and FDA-compliant Design History Files (DHF) and Manage project timelines and ensure compliance with quality systems and regulations.• Design Instruments and Implants using Pro/E and SolidWorks software. Work with prototype shops and vendors for rapid prototyping and evaluation• Perform design verification validation to meet specifications and assist with regulatory application to the FDA and other regulatory bodies.• Collaborate with operations and set up manufacturing and purchasing and supporting production introduction monitoring and address customer feedback.• Research industry trends and competitors to maintain cutting-edge technology and adhere to company policies, ethical standards, and compliance regulations.
