Senior Engineer - Multiple Positions
Qualitest
Senior Engineer - Multiple Positions
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.
Nearest Major Market: San Jose Nearest Secondary Market: Palo Alto