Ref No: AM17415
County Galway, Republic of Ireland
Manufacturing Engineer - County Galway.
In this role you will be responsible for performing a variety of technical and support roles to the production/manufacturing department.
• Provide technical support on all product and processing related issues.
• Manage production processes ensuring that target yield, capacity, throughput time and productivity are achieved.
• Experienced in Product Transfers and Manufacturing process set-up and scale-up.
• Apply “Lean” principles to production lines considering 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.
• Provide ongoing day to day support to Production; continually seeking to drive improvement in operation performance while also maintaining highest levels of regulatory conformance. Effectively troubleshoot production related issues, implementing “robust permanent fix” solutions.
• Establish and maintain appropriate manufacturing documentation including Equipment documentation, pFMEA's, TMV's, Bills of Materials, Part Numbers, Product routings, Work Instructions, Manufacturing procedures and Logs.
• Set up and order Product, Components, Consumables, and Material necessary for validation and production.
• Manage Tooling and Equipment spare parts inventory to support manufacturing capacity.
• Draft IQ/OQ/PQ protocols. Develop and execute required validations in line with regulatory requirements to include Equipment, Process & Product validations.
• 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 requirements:
• A minimum of 3 years’ experience working in a similar role. Catheter manufacturing knowledge is highly desirable. Engineering Degree or equivalent.
• Strong technical understanding of set-up and maintenance of manufacturing processes. Experience in validation, equipment design and Lean Manufacturing highly desirable.
• Proven technical expertise and competence across all aspects of the manufacturing engineering function including lean.
• Demonstrated expertise and detailed knowledge of the medical device industry.
• Equipment Procurement and Validation experience.
• Experience conducting IQ/OQ/PQ's 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.
• Good oral communication skills and capacity to represent the company to customer and representatives of regulatory bodies.
• Creative, continually learning and exploring new ideas.