Responsible for researching, developing, designing, and evaluating mechanical and electro-mechanical materials, components, assemblies, processes and/or equipment. Conduct feasibility studies to verify capability and functionality. Develop new concepts from initial design to market release. Direct support personnel and coordinates project activities. Write and submit intellectual property including patents. Maintain detailed documentation throughout all phases of research and development. Investigate and evaluate existing technologies. Review or coordinate vendor activities to support development. Establish and cultivate an extensive network of support to facilitate completion of assignments. Responsible for updating device drawings with new critical specification and tighter tolerancing using Design of Experiments (DOE) and Geometric Dimensioning and Tolerancing (GD&T) assessments. Collaborate with Manufacturing Engineers to update receiving inspection methods as required and support Gage R&R studies. Design and perform design verification testing per validated test methods. Ensure compliance with procedural and documentation requirements of FDA, ISO, ASTM and other regulatory bodies. Work with middle management on technical or business solutions and interact with vendors. Execute Design for Manufacturability, Corrective and Preventive Actions (CAPA), Process Failure Mode Effects Analysis (PFMEA), and/or Test Method Validation. Participate in the development of less experienced staff by setting an example, providing guidance and work direction, and offering counsel. Participate in determining goals and objectives for projects. Support new product development by reviewing and coordinating product/process development and testing with third party manufacturing companies. Plan and organize non-routine tasks with approval, maintain work schedule, and establish priorities of work assignments.