R&D Engineer

General Summary: The Engineer must perform electro-mechanical design and development functions for Class I and Class 2 medical devices throughout the entire product lifecycle in accordance with established design control and risk management procedures, design and execute verification and validation plans, execute engineering change oprders, and develop and maintain risk management and design history files. Essential Functions: 1. Implementation of design control and risk management procedures. 2. Work with cross functional team (CFT) to develop design and development plans, verification and validation plans, and risk management plans. 3. Work with CFT to define and/or review requirements and design specifications. 4. Plan and execute design verification and validation (V&V) testing of medical devices and their sub-systems. 5. Conduct design review meetings. 6. Develop and maintain risk management files (RMF) and design history files (DHF). 7. Facilitate the execution of design changes and engineering change orders (ECO). 8. Perform other duties and tasks as assigned by their supervisor/manager. 9. Strong interpersonal and communicative skills. 10. Strong problem-solving skills. 11. Knowledge of washer/disinfector design is an advantage. 12. Project management skills and experience is an advantage.