Great opportunity for a Senior Manufacturing Engineer to work for a small but highly successful Medical Device company in Galway.
- Support the finished device manufacturing subcontractors and suppliers to ensure that the product quality, regulatory & business requirements are met.
- Track and report progress across projects by reviewing schedules and due dates, identifying risks and assisting teams with contingency plans.
- Provide manufacturing engineering support to process and product development projects including responsibility for reporting on project activities.
- Review and contribute to supplier process validation and risk management activities.
- Support resolution of SCAR’s, CAPAs & NC’s ensuring effective solutions are identified, challenged and implemented.
- Assess and approve process changes ensuring product impact is appropriately considered.
- Compile any necessary equipment/capital authorisation requests supported with appropriate justifications and alternative options.
- Communicate effectively with all Internal & External Stakeholders.
- Collaborate with key suppliers and their production/manufacturing teams to drive and support process/product improvements/developments and lean initiatives.
- Ensure all health, safety and environmental requirements are met.
- The role will involve some European travel to suppliers (up to 20%).
- Educated to Degree Level (Level 7 or Level 8 FETAC) in a relevant engineering or science discipline.
- A minimum of 5 years’ relevant experience in the medical device industry in a team-based manufacturing or engineering role.
- Demonstrated ability to plan and complete tasks to defined timelines.
- Experience in performing process validation and risk management activities is required.
- Experience of managing internal/external relationships is required.
- Strong decision making and problem-solving skills. Excellent verbal and written communication skills.
- Self-motivated, with focus on Quality, Delivery and Cost.
- Experience with lean/six sigma and value improvement project experience is preferred.
- Nitinol stent and catheter delivery system manufacturing experience is an advantage.
If you are interested in this role, please send your resume to email@example.com or call me on 091 455 300 for more information.
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