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. Core Responsibilities: • 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.
196 days ago