Our client, a medical device company in Galway are currently looking to recruit a Manufacturing Engineer for their site in Galway.
The purpose of this role is to plan and execute product/process development activities and transfer such processes into the manufacturing environment. The successful candidate will start in R&D and move to production with a new product after 12/18 months.
- Work as part of a team with responsibility for the development of a new product in line with Merit?s
- Product Development Process with particular focus on the definition, development, testing and
- validation of device components, assemblies and packaging.
- Transfer with the product line into production as the technical lead.
- Can initiate own workload and ensures it is aligned to department and site goals.
- Leads complex projects with cross functional team.
- Continually assesses and reviews day to day manufacturing issues/practices.
- Can identify, gain approval and complete continuous improvement projects.
- Can prioritise issues as they arise.
- Completes technically challenging tasks and identifies appropriate resources when applicable.
- Uses established problem solving techniques to address challenging problems in production.
- Can compile and report KPI metrics for management review.
- Can effectively communicate line issues and offer solutions.
- Generates ECOs, protocols and prototypes under minimum direction.
- May supervise the work of technicians or others as required.
- Ensures all products and processes are developed in compliance with regulatory requirements.
- Performs other related duties and tasks as required.
- Educational experience of a Bachelor?s Degree in Engineering or technical field related to the department of assignment or industry with five years previous related experience, a Master?s Degree with three years previous related experience, or a Ph.D. A minimum of a Bachelor?s Degree is required for this position.
- Demonstrated track record in medical device product design & development from concept through commercialisation.
- Demonstrated experience in Risk Management and executing Failure Mode and Effects Analysis.
- Demonstrated experience in balloon catheter manufacturing in the areas of balloon forming, catheter assembly and coating are a distinct advantage.
- Strong analytical, problem solving and project management skills.
- Willing to take ownership of activities and work under own initiative.
- Excellent technical report writing skills.
- Working knowledge of general office computer software and hardware.
- 2D/3D CAD (preferably Solid works).
- Knowledge of ISO 13485, MDD and applicable FDA requirements.
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