Position Overview
Applies skill and dexterity in the sewing of tissue and non-tissue components used to produce medical devices, in keeping with regulatory and company guidelines.
Key Responsibilities:
• Use tools (e.g. needles, scissors, forceps, specialized tooling, microscope, magnifying lamp, MES) to perform assigned steps, in rotation, in the sewing assembly of stent/valves
• Perform verifications, against specifications, of completed steps, of stent and/or valve
• Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records, which may include entry into JDE and any other systems (e.g. MES), as required
• Perform line clearance, i.e., cleaning and sanitizing work stations at the start of the shift and when transitioning to next work orders
• Perform visual inspection under a microscope, and sequential review of colleagues' work
• Other incidental dutie...