Process Engineer - medical devices - Dublin.

Our client requires an enthusiastic and self-motivated Process Engineer, to support its developing medical device activities. The successful applicant will have expertise in medical device process development. As well as supporting existing products he/she will play a role in process development for new products.

The key outputs and deliverables of the role are as follows:
•      To define, validate and support the manufacturing process for existing implantable medical devices   
•      To produce a selection of appropriate manufacturing routes
•      To generate ISO13485 / FDA regulatory documentation
•      To monitor and record all aspects relating to the Clean Room (class 7) and control of the         manufacturing processes.

Interested applicants should possess the following:
• Educated to at least degree level in Mechanical/Production Engineering
• Experience of risk assessment - FMEA
• Experience of process validation
• Experience of Sterilisation
• GMP experience
• Experience in use of statistical tools
• Experience of medical device packaging systems - blister pack,  etc..

Although not essential, it is desirable if applicants have the following:
•       Knowledge and practical experience in rapid-prototyping technologies and processes
•       Expertise in the development of medical device moulding/overmoulding processes
• Experience of selection of materials for implantable medical devices
• Expertise in material and coatings selection for medical applications
• Expertise in the use of 3D CAD, Unigraphics NX or equivalent

Person specification:
The applicant must also possess strong interpersonal and organisation skills and should be able to demonstrate a strong understanding of GMP.

Based at the North Dublin plant the role may involve regular travel to the UK HQ for future product development.