Primary focus of this position is to assist R&D EU MDR and Manufacturing related testing, and associated test adjacent tasks. This would include receiving in, staging, labelling, tracking and prepping test product, trialing test methods to confirm and optimize test steps prior to validation.
Other tasks may include drafting portions of Test Protocols, Test Reports, SOPs, and Work Instructions, performing discovery and feasibility testing and documenting testing in lab notebooks, collecting and entering data, performing independent reviewer activities, supporting testing at outside laboratories, renewing confidentiality agreements, supporting calibration activities, conducting in-person lab safety training to new hires and new to the lab associates, conducting bi-monthly lab inspections, monitoring the Deionize Water system, and coordinating disposal of medical products and sharps with Environmental Health & Safety.