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Location: |
Dublin
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Qualifications: |
Degree |
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Experience: |
4-5 Years |
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Job Type: |
Permanent
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Salary: |
50-60,000 |
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Consultant: |
James Cassidy +353 1 685 45 45 |
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Process Engineer (Medical Device)
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Process Engineer (Medical Devices) Dublin
My client requires an enthusiastic and self-motivated Process Engineer, to support its developing business 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.
All applicants must 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.
Location:
Based at our Dublin plant the role may involve regular travel to the UK office for future product development.
For further information please contact James Cassidy on +353 1 685 45 45
Or apply online now for immediate consideration
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