Manufacturing Engineer

Sigmar Recruitment

Galway

My client, a leading Medical Device company has just launched an exciting new project and is looking for an experienced Manufacturing Engineer to be part of it. The company develops and manufactures leading, world-class medical devices in their Galway plant and also has a strongR&D facility. 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 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. Key requirements: Engineering Degreewith 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. 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. Is creative, continually learning and exploring new ideas. High level of flexibility required with regard to role and prioritisation of activities. A self-starter applies his/her own initiative in most situations. A good team player who works well in a small team environment. Capacity to maintain the highest levels of confidentiality internally and externally. Ability to stay connected to multiple projects simultaneously. If you are interested in this role, please send your resume to mslevin@sigmar.ie or call me on 091 455 300 for more information. This job originally appeared on RecruitIreland.com.

2225 days ago