Medical Device Tester

4 days ago


Limerick, Limerick, Ireland Edwards Lifesciences Full time
Job Description

We are seeking a skilled Medical Device Tester to join our team at Edwards Lifesciences.

About the Role:

The successful candidate will provide testing services in a laboratory environment, ensuring the highest standards of integrity and safety. This role involves routine testing services using established procedures/protocols, collecting environmental lab samples, performing data entry, and reviewing job functions for compliance with work instructions and SOPs.

Key Responsibilities:

  • Perform routine testing services using established procedures/protocols (e.g., sterility, bioburden, aseptic filtration, environmental collection and testing, receive, inspect, in-process solutions, etc.)
  • Collect environmental lab samples from multiple cleanrooms
  • Perform data entry of routine testing
  • Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records
  • Assist in testing validation/revalidation activities for critical systems and equipment under close supervision
  • Maintain basic equipment by following procedures and executing PM (preventative maintenance) per established schedule
  • Update operating procedures and ensure that specifications are in compliance with GMP, Environment and Safety regulations
  • Other incidental duties

Education and Experience:

Bachelor's Degree or equivalent in a related science field, 1 year of previous experience working in a laboratory environment required.

Additional Skills:

  • Good written and verbal communication, interpersonal, and relationship-building skills
  • Able to read, comprehend, write and speak English
  • Good computer skills, including usage of MS Office
  • Moderate knowledge of laboratory processes
  • Knowledge of QSR (Quality System Regulation), FDA (Food and Drug Administration), and ISO (International Organization for Standardization) regulations
  • Strict attention to detail
  • Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
  • Must be able to work in a team environment


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