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+353 1 662 1000
+353 21 422 1000
+44 28 90 325 325
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Tel +353 21 422 1000
Tel +44 28 90 325 325
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22 Feb 2021
One of my favourite clients in Cork has just opened some really interesting 2 year contract roles in
Manufacturing and Project Engineering.
Driven by expansion they need a number of committed and ambitious Engineers to help them role out advanced in their manufacturing lines and processes. If you have 5+ years in a Medical Device environment and experience of either the introduction of new Automated Manufacturing Lines or alternatively Product/Process Validations then give me a call on 087 3618142 or message me here for more.
About the Job:
Initiate, co-ordinate and complete assigned projects within the engineering department within budget
Complete Process / Product / Equipment Validations in conjunction with Quality/Validation group.
Conduct process feasibility trials / process DOE’s to determine appropriate/robust process windows
Prepare & execute OQ / PQ protocols for process / material changes as needed.
Work in conjunction with the Quality & Validation group to determine appropriate validation sampling and acceptance criteria.
Liaise with operations and technician group to prepare plan for validation builds.
Co-ordinate the execution of OQ / PQ builds.
Prepare OQ / PQ validation reports and deviations as required.
Conduct process capability analysis using Minitab.
Maintain and develop manufacturing process documentation and procedures. All process changes and modifications to be documented and tracked closely.
Responsible for dealing with process, product and quality issues to achieve long term solutions.
Lead and co-ordinate cost resolution projects year on year as per individual goals.
Lead and co-ordinate Risk Mitigation initiatives such as FMEA and Risk Assessments.
Working Knowledge of the following would be an advantage but not a requirement;
• Automated / Semi Automated assembly equipment. • Injection moulding and mould tools. • High precision Punch & Die Sets. • Heat sealing, ultrasonic welding, leak testing, vision systems. • OEE Line performance methodology. • Minitab/ Lean 6 Sigma techniques • Root Cause Analysis methodology • Microsoft Excel to an advanced level • AutoCAD.
Degree in Mechanical / Production Engineering or equivalent.
Minimum of 3 years relevant experience, preferably within Medical Device industry or other regulated environments.
Working knowledge of Product & Process validations essential.
Excellent Engineering ability
Strong organisational ability
Self motivation and drive
Demonstrate a high level of responsiveness to internal customers (eg. production)
Communication- strong written, oral and presentational skills.
For more on the role call Nigel on 087 3618142 or send your CV for consideration.