Job Description

Applies skill and dexterity in the assembly of components used to produce devices, in keeping with regulatory and company guidelines.

Key Responsibilities:

• Operate assigned equipment and has proficiency in at least one of the following operations - sealers, in-process packaging/labeling, ID tag processing, washers, ultrasonic cleaners, or ovens, laser cutting, ironing and relevant processes called out in the manufacturing of components - in appropriate settings and parameters, including selecting and utilizing fixtures and aids associated with assigned operations/tasks.
• Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records and may enter information into JDE.
• Perform line clearance, i.e., cleaning and sanitizing work stations at the start of the shift and when transitioning to next work orders. Self-assessment of work, sequential review of colleagues work, and providing constructive team feedback
• Other incidental duties: General work area housekeeping, material handling, printing

Education and Experience:
No previous related experience Required
Other: in Secondary level or equivalent previous GMP, clean room, medical device experience Preferred

Additional Skills:

• Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
• Ability to use required hand tools, hand eye coordination, and high manual dexterity
• Ability to understand and follow complex work documentation, using strict attention to detail
• Good communication skills
• Able to read, comprehend and speak English, and elementary-level understanding of numerical functions
• Proven ability to complete, retain, and incorporate training coursework in the performance of new and advanced work procedures
• Must be able to work with minimum supervision by following detailed manufacturing instructions
• Ability to effectively provide and accept feedback from colleagues based on sequential work reviews
• Work in a Team environment, primarily with colleagues and supervisor
• 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

Edwards Lifesciences