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

Assoc Heart Valve Specialist