Job Description
Our client, a medical devices manufacturer based in Galway, now seeks a suitable and experienced Process Development Engineer.
The successful candidate will plan and execute product/process development activities and transfer such processes into the manufacturing environment.
This is a permanent role based in Galway.
Responsibilities of Process Development Engineer:
- Work as part of a team with responsibility for the development of a new product in line with company?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.
- 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.
Requirements of Process Development Engineer:
? 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.
? 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.
? 2D/3D CAD (preferably Solid works).
? Knowledge of ISO 13485, MDD and applicable FDA requirements.
For more information and in strict confidence please send an up to date CV and cover note to John Reid at the RFT Group johnr@rftgroup.ie/ 01-2302400 / www.rftgroup.ie
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The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.