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 duties: General work area housekeeping, general sanitization of work area with approved chemicals, material handling, printing
Education and Experience:
• Secondary Education with previous sewing, GMP, clean room, medical device experience preferred
• No previous related experience required
Additional Skills:
• Ability to use small hand tools, hand eye coordination, and high manual dexterity
• Basic level of understanding of manufacturing procedures
• Basic computer skills, preferred
• Good hand eye coordination, required
• Ability to read, comprehend, and speak English, and good communication skills, required
• Must be able to work in a team environment and with minimum supervision by following detailed established manufacturing instructions
• Successful completion of ongoing job training of assembly process steps
• Strict attention to detail
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
