Ref No: AM17655
County Dublin, Republic of Ireland
Product Engineer - South Dublin.
This position is being offered as a 1-year fixed-term contract.
In this role you will provide support for the Research and Development team located in this brand new facility. Reporting to the R&D Lead you will support the large-scale R&D workstream as part of the key strategic MDR remediation programme, as well as lending support to the broader R&D team on a day-to-day basis. As part of an expanding and highly visible team you will have excellent opportunities to broaden your knowledge and develop your career within this exciting global business.
Key responsibilities include:
• Prepare R&D test samples & perform hands-on mechanical product testing & other studies as required for the MDR programme R&D workstream. Document and report on findings.
• Edit and prepare new/revised documents and forms that are submitted for the documentation control process, ensuring their compliance to ISO, GMP and FDA regulations.
• Be responsible for leading the engineering change request/order ECR/O documentation process.
• Maintain compliance to all applicable regulatory standards and current GMP procedures and practices.
• Organise/plan daily tasks to meet project timelines.
• Liaise with external vendors for laboratory equipment selection, installation / qualification.
• Have a proven ability to multitask and support multiple complex projects simultaneously.
• Contribute actively to R&D project planning.
• Identify and facilitate continuous improvement activities.
Interested applicants should have a solid educational background with a degree in engineering, quality or a relevant scientific discipline, with at least 3 years relevant work experience, or a Diploma with at least 5 years' relevant work experience.
You will have previous experience in an ISO accredited lab environment. Previous experience in a medical device testing laboratory preferred. You will have knowledge and understanding of Good Lab Practices (GLP) and Quality Management Systems (QMS).
The ideal candidate will display excellent multi-tasking, analytical, communication and prioritisation skills. Ability to work independently with minimal supervision as well as in a team environment. Be an excellent communicator with ability to run meetings and workshops.