Job Description

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 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, certified in at least two models while working at a level of greater independence with advanced level of quality and productivity . Perform verifications, against specifications, of completed steps, of stent and/or valve . 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 . 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 . Other incidental duties: General work area housekeeping, general sanitization of work area with approved chemicals, material handling, printing Education and Experience: Other: 2 Years years experience previous related experience Required or Secondary Education Preferred and Previous sewing, GMP, clean room, medical device experience Preferred Additional Skills: . Ability to use small hand tools, hand eye coordination, and high manual dexterity . Good understanding of manufacturing procedures . Ability to perform repairs on nonconformance errors . Ability to effectively provide and accept feedback from colleagues based on sequential work reviews . 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 . 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