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Manufacturing engineer medical devices

Cork
G&C Creations
Medical device engineer
Posted: 17 October
Offer description

Ensure quality of process and product as defined in appropriate OS and Material specifications.Ensure GMPs and system safety.Participate in FMEA, Control Plan, SOP and PPAP generation associated with product transfers and scale ups.Support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.Provide training for manufacturing team members.Interface with Materials Science, Design and Quality Assurance departments to provide customer with a quality product in a timely manner.Validation, Appraisal and support of machining suppliers and raw material suppliers.Communicate and participate in system and process troubleshooting with support team members and with external agents.Lead and participate cross functional and cross divisional process improvement initiatives.Provide engineering support for new Product and new process introduction, ensuring that all activities are completed and documented in accordance with Stryker New product Development Process.Process validation for products and processes; VP, IQ, OQ, PQ and associated documentation.Conduct Gauge R&R studies for products and new processes.Carry out structured problem solving.Application and development of statistical tools for use in driving continuous improvement projects.Provision of out-of-hours support to the business as required by management or as mandated by shutdowns and/or equipment failures.All other duties as assigned.Level 8 Degree in Engineering, Science or related discipline or equivalent Technical experience.Has 0- 2 years' experience in a manufacturing environment.Business understanding of operations and there impacts essential.High level of PC Skills required.Flexibility essential.Strong communication skills with both internal and external stakeholders.Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.The individual should enjoy working in a dynamic and results motivated team environment.Experience in an FDA regulated or regulated industry beneficial.Experience in a six sigma and Lean Manufacturing environment with proven improvement results.Green or Black Belt 6 Sigma qualifications.Ability to effectively work cross-functionally with A.O, Quality, etc.Job Type: Full-timePay: €45,000.00-€70,000.00 per yearWork Location: In person

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