Manufacturing Engineer Galway

Lotusworks

Galway

About Us. A valued and trusted partner to the world’s leading companies. We are committed to service excellence through our talented people who are empowered to be innovative and best in class. Location. Galway is a City and County which caters for everyone. Even though Galway City is one of the fastest growing cities it still retains that friendly feeling! With Culture, Dining, Socialising, Sport, Leisure and a state of the art University and College, there is a fantastic lifestyle on offer if you are relocating. If you already live in Galway, well then lucky you! Join us and work with us to deliver the excellent service we are renowned for with our clients. Be part of something great. Your Job Purpose: Perform a variety of technical and support roles to the production / manufacturing department. Your 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 trouble shoot 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. Requirements: 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. Has 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. Benefits. Life Assurance. Pension Contribution. Training & Educational Assistance (Engineers Ireland CPD Members. Healthcare Contribution. Annual GP Check-Up. Extra Annual Leave. Healthcare Screening. Not ready to apply, or have some questions? Call our Talent Specialist’s on 07191-69783 or Email jobs@lotusworks.com and we will be happy to help! Empowering talent we care about for over 27 years. LotusWorks is an Equal Opportunity Employer. This job originally appeared on RecruitIreland.com.

2586 days ago