Job Summary:
The Manufacturing Engineer 2 (Test Method Validation) is responsible for performing and documenting validations of medical device manufacturing processes. This role requires a strong analytical and problem-solving skillset, with the ability to handle multiple projects simultaneously.
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 and maintain accurate documentation consistent with the requirements of pertinent regulations and Cook's Quality Management System where applicable.
* Deputise for Senior Manufacturing Engineer (Test Method Validation).
Requirements:
* Bachelor's degree in engineering or a related field (desired).
* Minimum of 3 years' Validation/relevant experience.
* Strong interpersonal and organisational skills.
* Able to communicate at all levels of the organisation.
* Proven project planning skills and the ability to execute projects in a timely and effective manner.
About the Role:
Cook Medical has been in Limerick since 1996, starting out with labeling and distribution and steadily growing and evolving to include manufacturing, centralised customer support and collaborative product development in the Innovation Centre.
This location currently employs over 1000 people and manufactures 10% of Cook's products for global markets.