Manufacturing Engineer 2
About the Role:
* Develop and execute test method validations for equipment according to current quality management system and regulatory standards.
* Implement medical device manufacturing processes as assigned.
* Identify equipment/fixture installation qualification requirements.
* Characterize processes and their outputs/acceptance criteria.
* Maintain accurate documentation consistent with pertinent regulations and quality management systems.
* Support senior manufacturing engineer in test method validation.
Responsibilities and Requirements:
1. Execute test method validations for equipment according to quality management system and regulatory standards.
2. Prepare written validation reports that meet regulatory/company standards.
3. Verify testing, manage projects, and maintain timely records.
4. Apply analytical and problem-solving skills, demonstrate a positive attitude, and show strong work ethic.
5. Handle multiple projects simultaneously with minimal supervision.
6. Meet training requirements, seek opportunities for growth, and development.
Qualifications and Experience:
* Bachelor's degree in engineering or related field is desired.
* Minimum three years' experience in validation/relevant field is required.
* Strong interpersonal and organizational skills with ability to communicate at all levels of organization.
* Proven project planning skills with ability to execute projects efficiently.
About Our Location:
Our European headquarters has been located in Limerick since 1996. We manufacture products for global markets and employ over 1000 people.