Our client a start-up medical device company based in Galway is currently seeking a Manufacturing Engineer to join their team. Reporting to Operations Engineer the manufacturing engineer will be responsible for the identification and implementation of manufacturing process improvements and to complete assigned work in a manner which complies with the company’s Quality Management System. Client ismoving into operation stage with product require someone to work on scale up of product and act as point of contact with venbdors and third partner manufacturers. Can look at Senior and/or Engineer level
Identification and implementation of manufacturing process improvements.
Completion of all assigned work activities in adherence to the company’s Quality Management System which has been developed in compliance to ISO 13485:2003 and FDA Quality System Regulations CFR 21 Part 820.
Design, development, verification and implementation of process improvements and process aids/fixturing.
Equipment specification & procurement and coordination of installation, commissioning and validation.
Creation and update of manufacturing/inspection procedures compliant with GMP.
Root cause analysis and implementation of corrective actions as part of CAPA process.
Development of product packaging and packaging processes in conjunction with R&D.
Monitoring of process yield.
Providing ongoing input to PFMEA.
Processing of change notifications and completion of technology transfer activities in conjunction with manufacturing sub-contractor.
Participation at operations, manufacturing sub-contractor and vendor meetings.
B.Eng in Engineering/Biomedical/Manufacturing Technology (Hons degree an advantage).
Minimum 4 years relevant work experience in a Medical Device environment.
Strong understanding of medical device quality & regulatory systems.
Strong communication & organizational skills.
Ability to work in a team.
Strong analytical and problem solving skills.
Experience of fixture/process aid development.
Experience of manufacturing process development and process validations.
Working knowledge of a 3D CAD package (Solidworks an advantage).
Experience of applying Lean/Six Sigma techniques to improve manufacturing processes (Green/Black Belt certification an advantage).
Understanding of EHS and equipment safety standards.
James Cassidy | Tel: +353 (0) 1 5079250