Overview The Manufacturing Engineer 2 (Test Method Validation) performs and documents validations of medical device manufacturing processes.
Reporting to: Manager, Manufacturing Engineering 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.
Written preparation of applicable validation reports that meet regulatory/company standards.
Verification testing Project management Maintain accurate and timely reports and records Must have excellent analytical and problem solving skills Positive attitude, strong work ethic and self-motivated.
Ability to handle multiple projects simultaneously and work with minimal supervision.
Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
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) Ensure that Cook's Code of Conduct is considered in all business matters carried out on Cook's behalf.
Qualifications Bachelor's degree is desired, preferably in engineering or a related field and / or relevant experience.
Minimum of 3 years' Validation/relevant experience is required.
Strong interpersonal and organisational skills and the ability to communicate at all levels of the organisation.
Willingness to seek out and drive improvement.
Proven project planning skills and the ability to execute projects in a timely and effective manner.
Team Player with ability to develop strong working relationships.
Demonstrated problem solving skills.
Highly motivated individual, self-starter with a passion for excellence.
Must be able to work in a fast-paced environment.
Excellent attention to detail.
About Cook Limerick 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 on to collaborative product development in the Innovation Centre.
The Ireland 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.
Our employee benefits include: 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 To be considered for this role you will be redirected to and must complete the application process on our careers page.
To start the process click the Continue to Application or Login/Register to apply button below.