Job Description
The Manufacturing Engineer 2 (Test Method Validation) is responsible for performing and documenting validations of medical device manufacturing processes.
Key Responsibilities:
* Develop and execute Test Method Validations for Test Equipment per current QMS/Regulatory standards.
* Validate and implement medical device manufacturing processes as assigned.
* Identify equipment/fixture installation qualification requirements.
* Characterization of processes and their outputs/acceptance criteria.
* Prepare written validation reports that meet regulatory/company standards.
* Verify testing results and project manage multiple projects simultaneously.
Requirements:
* Bachelor's degree in engineering or a related field, or equivalent experience.
* Minimum of 3 years' Validation/relevant experience required.
* Excellent analytical, problem-solving, and communication skills.
* Ability to work with minimal supervision and maintain accurate records.
* Demonstrated project planning skills and ability to execute projects in a timely manner.
* Team player with ability to develop strong working relationships.
About Cook Ireland Ltd:
Cook Medical has been in Limerick since 1996, starting out with labeling and distribution. Our European headquarters houses our EMEA Support Centre and currently employs over 1000 people. We manufacture 10% of Cook's products for global markets and offer various employee benefits, including a hybrid work model and company-sponsored pension scheme.