Senior Manufacturing Support Engineer
Our client an exciting early stage medical device company based in Galway currently seeks a Senior Manufacturing Support Engineer to join their team. Reporting to the Operations Director this position is a highly collaborative role working closely with R&D, QA and our key suppliers to ensure the effective supply of high quality finished product for our product development projects, clinical and commercial supply. The role will involve some European travel to suppliers
Role/Responsibilities
Provide manufacturing engineering support to R&D projects
Support manufacturing transfer and scale up activities to ensure manufacturing documentation is robust and unambiguous
Resolve quality and technical issues relating to product supply ensuring design control is maintained at all times
Identify and implement effective solutions and preventative actions in response to technical and CAPA related issues
Review and approve manufacturing procedures, equipment specifications and process validation protocols / reports
Compile any necessary equipment/capital authorisation requests supported with appropriate justifications and alternative options
Collaborate with key suppliers and their production/manufacturing teams to drive and support process and product improvements/developments
Provide monthly reports on manufacturing status to senior management
Provide weekly/daily report on manufacturing status at key project and supplier meetings
Engage with alternate suppliers as required to understand, document and quantify their manufacturing, validation and scale up capabilities
Ensure equipment complies with all health, safety and environmental requirements
Undertake other activities from time to time as requested by Management
Skills/Experience
Educated to Degree Level (Level 7 or Level 8 FETAC) in a relevant engineering or science discipline.
A minimum of 7 years’ relevant experience in the medical device industry in a team based manufacturing or engineering role with lean/six sigma and value improvement project experience. Nitinol stent and catheter delivery system manufacturing experience an advantage.
James Cassidy | Tel: +353 (0) 1 5079250
