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  • DUBLIN 2
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  • Job reference number:15276025
  • Client ID:RI/AM15554
  • Posted on:13-SEP-2017
  • Location:GALWAY
  • Job type:PERMANENT

Manufacturing Engineer - County Galway.

Job Overview:

The Manufacturing Engineer is responsible for performing a variety of technical and support roles to the production / manufacturing department.

Key Responsibilities

• Set up a new manufacturing process.
• Manage the successful scale up and commercialisation of this new process ensuring that target yield, capacity, throughput time and productivity are achieved.
• Design, procure and construct "Lean" production lines taking into account flow optimisation, throughput time, product movement, layout and space.
• Specification, procurement, installation, and validation of manufacturing equipment. This will include on site Factory Acceptance Testing of equipment.
• Set up preventive maintenance and calibration routines.
• Lead the knowledge transfer of this new manufacturing process and provide training to Product Builders and Technicians.
• Provide ongoing day to day support to Production; continually seek to drive improvement in operation performance while also maintaining highest levels of regulatory conformance. Effectively troubleshoot issues implementing "robust permanent fix" solutions.
• Establish and maintain appropriate manufacturing documentation including equipment documentation, pFMEAs, TMVs, Bills of Materials, Part Numbers, Product routings, Manufacturing procedures and Logs.
• Set up and order product, components, consumables, and material necessary for validation and production.
• Draft IQ/OQ/PQ protocols. Develop and execute required validations in line with regulatory requirements to include equipment, process & product validations.
• Generate and gain approval for project budgets and subsequently manage expense and capital expenditure in line with this budget.
• Partner with R&D, Quality and Operations to ensure that the transition of products through R&D, product approval and manufacturing scale up are smooth, timely and cost effective

Qualifications and Experience Sought:

• Engineering Degree or equivalent.
• A minimum of 3 years’ experience in a similar role
• Strong technical understanding of set up and maintenance of manufacturing processes, experience in validation, equipment design and Lean Manufacturing highly desirable.

• Demonstrated expertise and detailed knowledge of the medical device industry and in particular combination medical devices. Familiarity with drug and other coating techniques.
• Experienced in product transfers and manufacturing process set-up and scale-up.
• Equipment procurement and validation experience.
• Proven technical expertise and competence across all aspects of manufacturing engineering function including lean.
• Will have prepared SOPs, conducted IQ/OQ/PQs and/or validations previously in a regulated environment.
• Effective knowledge of the regulatory environment in which the business operates.
• Proven written and oral communication skills and an ability to prepare competent business cases.
• An analytical approach to problem solving.
• Oral communication skills and capacity to represent the company to customer and representatives of regulatory bodies.
• Creative, continually learning and exploring new ideas.
• High level of flexibility required with regard to role and prioritisation of activities
• A good team player who works well in a small team environment.
• Ability to stay connected to multiple projects simultaneously.

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