Manufacturing Engineer – Galway
If you have experience working in a regulated medical device environment with a focus on meeting quality service and cost objectives then this is the job for you!
- Work as part of the NPI team to drive product and process improvements.
- Manage new designs through product lifecycle into manufacturing.
- Work closely with experts to ensure all new product fit within existing manufacturing capability.
- Work closely with Lean and operations teams to ensure that any new processes developed meet manufacturing standards.
- Manage a variable workload across different projects to meet NPI requirements.
- Design and introduce manufacturing processes for new products.
- Ensure that complete and effective validations are carried out on all processes before transferring to manufacture including IQ, OQ, PQ & PPQ.
- Implement permanent and effective technical / system solutions to problems.
- Maintain high compliance standards in line with Medical Devices manufacturing requirements.
- Applying Lean principles to identify and develop improvements.
- Investigate new process technologies and evaluate potential competitive advantage.
- Manage external relationships with Technology providers / Suppliers.
- Ensure that all Health, Safety and Environmental requirements are fulfilled.
- BSc. Engineering degree, or equivalent qualification.
- 2+ years’ experience in a similar role.
- Strong technical background and capabilities.
- Knowledge of ISO and FDA compliance with an emphasis on validation.
- Knowledge of six sigma methodology and lean manufacturing principles.
- Ability to solve problems with innovative and cost-effective solutions.
- AutoCAD, Solid works and Minitab experience preferable.
- Knowledge of equipment, process and product validation processes.
- Previous experience of working within a medical device environment.
- Strong mechanical background with a good working knowledge of metals & plastics processing a distinct advantage.
- Experience in the development of test methods and associated product testing.
- Knowledge of change management in medical device environment advantageous
- Must be authorised to work in Ireland.
Please contact Emer Smith to discuss in confidence