Endovascular Research And Development Co-Op
Provided continuous support towards the installation, operation, and process qualification of a catheter extrusion line while maintaining compliance per Code of Federal Regulations Title 21 Part 820 Quality System Regulations. Executed a successful planned engineering study and created a testing procedure for the catheter measurement device that supported its validation through objective evidence and procedural documentation. Successfully initiated and completed numerous tooling… Show more Provided continuous support towards the installation, operation, and process qualification of a catheter extrusion line while maintaining compliance per Code of Federal Regulations Title 21 Part 820 Quality System Regulations. Executed a successful planned engineering study and created a testing procedure for the catheter measurement device that supported its validation through objective evidence and procedural documentation. Successfully initiated and completed numerous tooling verification documents and their execution for the catheter extrusion line’s various tools such as the melt extruder, melt pump, and cooling tank within given time constraints. Analyzed part specification documents for accuracy and compatibility with the design history file documents and communicated findings throughout the product development team to correct errors and remove discrepancies. Show less