Experience

Wellstat Diagnostics

• Biotechnology
• 1 - 100 Employee

• Medical Device Developer

  • Jun 2008 - Present

  • Design and develop components and subsystems of a clinical diagnostic device according to Design Control • Generate test protocols (TP) and test reports (TR) for experimental studies • Evaluate capabilities of new designs to meet design requirements • Identify root causes of system design problems and resolve the problems • Conduct technical and design reviews • Optimize the performance of devices under development • Develop automated sequences of operations for immunoassay • Verify system performance against system requirement specifications • Evaluate the performance of system and subsystems throughout the development cycle • Conduct studies in support of company’s commercialization of a clinical diagnostic device • Perform statistical analysis on large datasets • Perform duties per GMP