About The Role

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 – needles, scissors, forceps, specialized tooling, microscope – to perform assigned steps, in rotation, in the sewing assembly of valves
Perform verifications, against specifications, of completed steps, and successive checks on steps completed by work team colleagues
Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records
On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period
Other incidental duties: General work area housekeeping

Education and Experience

H.S. Diploma or equivalent Previous sewing, GMP, clean room, medical device experience Preferred
Other: No previous related experience Required

Additional Skills

Basic computer skills required
Good hand eye coordination, required
Ability to read, interpret and comprehend policies and procedures (English Speaking, preferred)
Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
Must be able to work in a team environment and with minimum supervision by following detailed 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