Summary from listing
The Test Engineer designs, builds, and validates test methods for medical devices and single-use disposables in an ISO 13485 and FDA QSR-compliant environment. The role supports R&D through production, including verification and validation testing, test method development, custom fixture and automated equipment design, equipment validation, documentation, statistical data analysis, and communication of test findings. Candidates need a relevant bachelor’s degree or equivalent trade experience, 2–5 years of medical-device or regulated-industry engineering experience, knowledge of applicable quality and risk-management standards, and proficiency with data acquisition, MATLAB or Minitab, and mechanical test equipment.
