Manufacturing Engineer in Galway
Our client a medical device company based in Galway has a Manufacturing Engineer job for their site.
This exciting new role is within the Design Services department and will be responsible for providing manufacturing input to the Design Process, ensuring design for manufacturing principals are employed, developing the production line and supply chain and providing manufacturing engineering support to projects transferring to a commercial steady state production environment.
The Manufacturing Engineer will involve working closely with project leaders and the manufacturing teams to ensure new products are successfully transferred to volume production.
This position requires a candidate with medical device products and manufacturing and process development experience in the medical device arena.
- Working as part of the Design Services/Device Manufacturing groups, the successful candidate will be responsible for the following:
- Developing manufacturing processes from prototyping to full scale production.
- The manufacture and testing of prototypes.
- The implementation of best practice Design for Manufacturing Principals
- Applying new technologies and methodologies to optimise process design & performance.
- Design/Source Equipment and Tooling required to meet both the capability & capacity requirements
- Implement lean manufacturing initiatives such as cell layout design based on detailed Takt time analysis, identify and eliminate sources of waste activity, implement Kanban Systems and 5S Principles
- Setting up of the manufacturing equipment/production lines with clearly defined metrics and trained personnel
- Dealing with external customers on technical and quality items.
- Managing the successful transfer of new products through the DS project process to volume manufacturing.
- Development, resourcing and execution of project plans for the transfer of products to volume manufacturing.
- Identify and execute continuous improvement projects that improve Key Performance Indicators (KPIs)
- Present updates to management and customers regarding cell performance and continuous improvement status
- Resolve quality and technical issues such that impact on product supply to customers is minimized
- Generation of Project Documentation - pFMEAs, Process Validation Protocols & Reports, Manufacturing Procedures, BOMS, Routers, etc
- Engineering degree or equivalent.
- 3+yrs industry experience with manufacturing process design and optimisation in controlled manufacturing and/or process development environment. Medical Device experience preferable.
- Experience of managing product transfers from the R&D into the production/commercial environment a distinct advantage
- Validation background including IQ/OQ/PQ/PPQ.
- Experience in using Six Sigma methodology for process improvement (e.g. DMAIC) and problem solving (e.g. 6-step approach) in a production environment
- Experienced in statistical analysis and use of Minitab
- It is essential that the candidate will be highly innovative, motivated and organised and have excellent planning and communication skills
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