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. in Engineering or equivalent.
- 3+ years’ experience working in a similar role.
- Strong technical understanding of set up and maintenance of manufacturing processes.
- Experience in validation, equipment design and Lean Manufacturing desirable.
- Proven technical expertise and competence across all aspects of manufacturing engineering function.
- Demonstrated expertise and detailed knowledge of the medical device industry.
- Equipment Procurement and Validation experience.
- Has experience conducting IQ/OQ/PQs and validations.
- Effective knowledge of the regulatory environment.
- High level of flexibility required with regard to role and prioritisation of activities.
- A good team player who works well in a team environment.
- Ability to stay connected to multiple projects simultaneously.
- Must be authorised to work in Ireland.
Please contact Emer Moore to discuss in confidence