Job Title: Manufacturing Engineer 2 (Test Method Validation)
Develop and execute Test Method Validations for Test Equipment per current QMS/Regulatory standards.
Key Responsibilities:
* 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.
Project Management Skills:
* Maintain accurate and timely reports and records.
* Verify testing results.
* Manage multiple projects simultaneously.
Requirements:
* Bachelor's degree in engineering or a related field (desired).
* Minimum 3 years' Validation/relevant experience required.
* Strong interpersonal and organisational skills.
* Able to communicate at all levels of the organisation.
* Willingsness to drive improvement.
* Proven project planning skills.
* Team Player with ability to develop strong working relationships.
* Demonstrated problem solving skills.
* Highly motivated individual, self-starter with a passion for excellence.
About Cook Limerick:
Cook Medical has been in Limerick since 1996, starting out with labeling and distribution. The location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 1000 people and manufactures 10% of Cook's products for global markets.
Employee Benefits:
* Hybrid Work Model.
* Company sponsored Defined Contribution pension scheme.
* Medical Health Insurance cover for you and your immediate family.
* Life Assurance and Income Protection cover.
* Educational Assistance.
* Performance related Bonus.
* Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks.
* Fully equipped gym on site.
* 39-hour week with flexible start & finish times.
* Paid time off to participate in volunteer activities.
* Free parking.
* Subsidised restaurant.
* Sports & Social club.