Senior Packager, Pilot

Edwards Lifesciences•Irvine, CA

17d

About The Position

The Senior Packager performs transcatheter heart valve (THV) packaging work to support manufacturing and production activities, following established procedures and guidance. The role packages products and generates and applies labels while ensuring strict compliance with quality, regulatory, and standard operating procedure requirements. The Senior Packager works independently at a fully mastered level, maintaining high quality and productivity, and may provide training or coaching to more junior employees.

Requirements

At least 4 years of related experience, including GMP, clean-room, and medical-device experience.
Ability to read, comprehend, write, and speak English, including giving and receiving feedback.
Ability to work with minimum supervision by following detailed manufacturing instructions and to work in a team environment.
Strong attention to detail and ability to comply with standards.
Ability to perform all packaging operations.
Full understanding of manufacturing procedures and pouch peel-test integrity operations.
Good computer skills and an in-depth understanding of documentation and JDE transactions.
Adherence to Edwards Environmental Health and Safety and Quality guidelines for clean-room medical-device manufacturing.

Nice To Haves

High school diploma or equivalent.
Ability to complete, retain, and apply training coursework when performing new and advanced work procedures.

Responsibilities

Inspect labels and packaging to ensure quality, regulatory, and SOP standards are met.
Perform inside and outer packaging procedures independently at a fully mastered level.
Package products, generate labels, and apply labels to packaging in accordance with quality, regulatory, and SOP standards.
Relabel and repackage warehouse returns and NCR repairs.
Perform line clearance by cleaning and sanitizing workstations at the start of shifts and when transitioning between work orders.
Ensure required components and tools are ready for the build.
Perform integrity peel-testing of inside packaging pouches.
Follow work instructions and SOPs, record traceable information on device history records, and enter information into JDE as needed, including issuing packaging materials from floor-stock inventory.
Palletize products for shipment to outside sterilization services, following drawings and placing Biological Indicators correctly per SOPs.
Provide training and may coach junior employees; evaluate and demonstrate the correct approach to other employees' work in the absence of the Lead.
Follow company rules and requirements, including pandemic protocols and Environmental Health and Safety rules, and take appropriate measures to prevent injuries and pollution.