Job Description: Senior Manufacturing Engineer (Test Method Validation)
Reporting to the Manager, Manufacturing Engineering, this role involves developing and executing test method validations for test equipment according to current QMS/Regulatory standards.
Responsibilities:
* Validate and implement medical device manufacturing processes as assigned
* Identify equipment/fixture installation qualification requirements
* Characterize processes and their outputs/acceptance criteria
* Prepare written validation reports that meet regulatory/company standards
* Verify testing
* Manage projects
* Maintain accurate and timely reports and records
Requirements:
* Bachelor's degree in engineering or a related field, with a minimum of 5 years' validation/relevant experience
* Strong interpersonal and organisational skills
* Able to communicate at all levels of the organisation
* Proven project planning skills and ability to execute projects in a timely and effective manner
* Team player with ability to develop strong working relationships
* Demonstrated problem solving skills
About Cook Ireland LTD:
Cook Medical has been based in Limerick since 1996, starting out with labeling and distribution. The company has steadily grown and evolved to include manufacturing, centralised customer support, and collaborative product development in the Innovation Centre.
The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs over 1000 people and manufactures 10% of Cook's products for global markets.
We offer a range of benefits, including a hybrid work model, company-sponsored pension scheme, medical health insurance, life assurance, income protection cover, educational assistance, and more.