Senior Engineer - Multiple Positions (Santa Clara, CA, US, 95054) at Qualitest

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.