**Overview of the Manufacturing Engineer 2 (Test Method Validation)**
The Manufacturing Engineer 2 (Test Method Validation) plays a crucial role in ensuring the quality and safety of medical device manufacturing processes. This position reports directly to the Manager, Manufacturing Engineering.
Responsibilities:
* Develop and execute Test Method Validations for Test Equipment according to current QMS/Regulatory standards.
* 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 through project management.
* Maintain accurate and timely reports and records.
Key Requirements:
* Excellent analytical and problem-solving skills.
* A positive attitude, strong work ethic, and self-motivation.
* The ability to handle multiple projects simultaneously and work with minimal supervision.
* Maintenance of all training requirements for the position, while seeking opportunities for continuous development and growth.
Qualifications:
* Bachelor's degree in engineering or a related field, or relevant experience.
* Minimum of 3 years' Validation/relevant experience.
* Strong interpersonal and organisational skills, with 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.
* A team player with the ability to develop strong working relationships.
* Demonstrated problem-solving skills.
* A highly motivated individual, self-starter with a passion for excellence.
* The ability to work in a fast-paced environment.
* Excellent attention to detail.
About Cook Medical in Limerick:
Cook Medical has been operating in Limerick since 1996, starting with labeling and distribution and growing to include manufacturing, centralised customer support, and collaborative product development in the Innovation Centre.
This location serves as our European headquarters and houses our EMEA Support Centre, currently employing over 1000 people and manufacturing 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
* 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