A multinational Medical Device client in Galway is seeking an experienced Manufacturing Engineer to maximise it`s production capabilities and lead LEAN projects. A strong salary and benefits package is on offer for the right candidate. About the Job: Prepare and approve procedures, BOM’s and shop floor documentation. Generate and approve change requests. Prepare/Review Master Validation Plans, FMEA’s, and Control Plans. Process owner of Non-Conformance - getting to source of the issue and implementing Corrective Action. Ownership of driving this process for assigned projects. Drive continuous improvement and innovation Projects. Ensure all products and processes are developed in compliance with regulatory requirements. Continually assess and review day to day manufacturing issues, consistently striving for improvement by analysing, developing and implementing manufacturing techniques and materials to provide robust improvements in compliance with applicable regulatory requirements. Implement appropriate process controls on to manufacturing processes for robust and repeatable commercial product manufacturing. Ensure that all Engineering work and designs are carried out to appropriate GMP, QA/Regulatory Authority standards and Environmental Health and Safety standards. Day to Day engineering support of a variety of packaging and medical device production lines. Support the development of new processes in conjunction with Manufacturing / R&D Engineering ensuring that new processes are stable and capable. Successfully complete validations and process improvements using statistical tools and six sigma techniques. Support the development of in-house Subject Matter Experts (SME) across the range of core technologies. About You: Minimum of 5 years of professional experience in a responsible Process Development/Manufacturing Engineering role within the Medical Device/Healthcare. Degree in Mechanical Engineering/Manufacturing Engineering/Quality Engineering/Science or related discipline. Ability to supervise/Lead a team to meet project deadlines. Strong interpersonal and influencing skills. Demonstrable PC skills including standard Microsoft Office packages as well as ability to understand and learn customised computer software programs. Six Sigma Green or Black Belt will have a significant advantage. Proven Implementation of Lean Manufacturing experience essential. Demonstrated validation experience is highly desirable. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.
67 days ago