Qualitest

Develop and execute test methods and plans for surgical robotics system V&V, analyze data, manage projects, design prototypes and test fixtures, and author protocols and manufacturing instructions. | Experience with FDA and IEC regulations, statistical analysis, SolidWorks design, protocol authoring in JAMA, and willingness to travel extensively. | Developing inspection, performance variable test methods and plans for a Surgical Robotics system to conduct Design Verification and Validation (V&V) activities as per FDA and IEC Regulations. • Executing prelim runs, dry-runs and performing GR&R Engineering studies using statistical methods. • Collecting and analyzing the data using Minitab and summarizing the results into an engineering report. • Managing own projects, as well as supporting other engineers to develop system requirements and test fixtures development activities. • Authorizing protocols, requirements and plans in JAMA followed by Good Documentation Practices (GDP) and reporting to senior management. • Designing prototypes using SolidWorks, qualifying, and documenting test fixtures, equipment, and systems. • Drafting IQ/OQ protocols to ensure the equipment is installed and operates according to the specifications. • Writing Manufacturing Processing Instructions (MPI's) for sub systems. Up to 100% travel required. Reports to company headquarters in Chicago, IL. Roving employee will work at various unknown client sites throughout the U.S.