For over 50 years, the Critical Care product group within Edwards Lifesciences (NYSE: EW) has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because we're committed to creating a world where every patient who should be monitored will be monitored with smart technology.
If you're a dynamic and passionate person who is eager to contribute to innovative, industry-leading advanced technology, we invite you to explore our career opportunities.
We believe those who join us will be part of an inspiring journey to improve the quality of care for millions of patients around the world.
Appendix:
On June 3, 2024, Edwards announced that it had entered into a definitive agreement to sell its Critical Care product group to BD (Becton, Dickinson and Company) (NYSE: BDX). It remains business as usual at Edwards until the transaction closes. More information on Edwards' announcement about the acquisition can be found here:
https://www.edwards.com/newsroom/news/2024-06-03-edwards-lifesciences-to-sell-critical-care-to-bd
Applies skill and dexterity in the assembly of components into finished devices, in keeping with regulatory and company guidelines.
Performs all routine and special tasks related to the sterilization process and equipment maintenance to assure availability and quality of sterile products, with strict adherence to all EH&S guidelines.
Key Responsibilities:
Product Sterilization – Receive, prepare, and inspect products and documentation for completeness and accuracy, including moving products through pre-conditioning, sterilization, aeration, and quarantine, while assuring compliance with process parameters; verifying temperature, humidity charts, and sterilization records; and scheduling load processing according to customer needs and equipment availability. These activities may also require communicating with internal and/or external customers.
Record Keeping and Reporting – Maintain documents according to good manufacturing practices, including completing all required forms and records according to established procedures; report process alarms, reason, and corrective action to supervisors immediately; and communicating critical information about the department operation to assure continuity in the activities in progress to next shift.
Compliance and Personal Computer Operations – 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. Use of PCs to prepare sterilization records and files data, retrieve information for customers, and close operations in work orders in JDE or applicable systems.
Biological Indicators - Prepare, place and remove B.1's in loads according to procedures and specifications, ensuring that the correct amount and positioning is used.
Fork Lift Operation – Operate forklift equipment to unload carriers, move product into a two levels pre-conditioning and aeration room and quarantine areas.
Troubleshooting – Troubleshoot sterilizer's valves or systems, boilers, air compressors, gas scrubbers as trained to avoid sterilization process deviations and delays, and support maintenance technician as necessary.
Product Cycle Validations – Provide support during product and cycle validation by handling samples, removing internal BI's placing temperature measuring devices on loads and taking checkpoints of calibration cycles.
Area and Equipment Maintenance – Maintain restricted entrance areas clean and organized, rinse sterilizer interiors as per posted schedule, and help Maintenance Technician to perform corrective maintenance.
On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period.
Other incidental duties:
Participate in lean events; update knowledge and applications of lean Tools, 6S, Six Sigma, as required; participate in all HR training and development plans determined by the company.
Education and Experience:
Associate's Degree or equivalent, required.
Experience in sterilization or mechanical processes, preferred.
Experience in Sterilization using Ethylene Oxide, preferred.
Availability to work rotating shifts, holidays, and weekends.
Additional Skills:
Good communication skills.
Able to read, comprehend, and speak English sufficiently to utilize computer-based systems.
Adhere to Edwards Environmental Health and Safety and Quality guidelines as they relate to medical device manufacturing.
Must be able to work with minimum supervision by following detailed maintenance instructions
Work in a Team environment.
Basic computer skills.
Experience in Sterilization using Ethylene Oxide is a plus.
Satisfactory evaluation by management after completing ongoing technical sterilization operator training.
Must be able to work in a high safety sensitive position.
Moderate knowledge of sterilization process and equipment maintenance.
Ability to provide feedback in a professional, direct, and tactful manner.
Ability to effectively communicate with internal and/or external customers.
Accountable to adhere to applicable Edwards Environmental, Health and Safety and Quality System requirements to ensure our products and services consistently meet customer and regulatory.
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.
Ensure proper handling, storage and disposal of all waste generated in the facility according to applicable laws within the waste management program (RCRA). Prepare regulatory and/or internal reports, complete waste determinations, sign waste manifests and coordinate proper training sessions to affected personnel.
