Manufacturing Engineer II - EU MDR - 23 month contract - Medtronic Athlone.

MedtronicAt Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress and deliver meaningful innovations.Our Purpose At our R&D Department, in Medtronic Athlone we focus on providing stable, flexible and cost-effective solutions to enhance our processes and systems that produce the highest quality products through the deployment of innovative engineering projects and solutions. Reporting to the R&D manager, EU MDR Manufacturing Engineers are directly involved in understanding and providing EU MDR compliance solutions and documentation throughout the project lifecycle, designed to continuously improve our manufacturing processes, systems, quality and regulatory compliance to the highest standards. Come for a job, stay for a career!A Day in The Life Of: As part of our EU MDR compliance project, work with manufacturing and validation engineers in coordinating, and executing component and assembly validations according to agreed project schedules/timelines.Work with validation team in terms of establishing gaps in the Project Validation Master Plans and Reports, IQ, OQ and PQ Plans and Reports.Risk Management – As part of a team, support the completion of risk management to include the use of tools such as Failure Modes Effect Analysis (FMEA), Fault Tree Analysis etc. to all product groups.Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.Suggest relevant changes to procedures and update to standard operating procedures as necessary.Liaise with cross functional team members, developing strong partnering relationships with these to establish inspection methods which ensure effective product acceptance actives. Work with the R&D team to find novel solutions to problems and the opportunity to develop innovative solutions. Key Skills & Experience Level 8 Degree in a relevant Quality/Engineering/Manufacturing related discipline.Preferably with 3–5 years relevant experience in a medical devices or similar fast-paced regulated environment.Knowledge of plastic processing techniques such as Extrusion, Injection Moulding, Blow Moulding, Assembly, etc.Medical Device Process Validation experience a key skill.Knowledgeable in Quality Systems, validation standards, statistical data analysis, policies, procedures, and methodologies.Skilled in the use of Solidworks or other 3D Modelling software is beneficial.Dynamic team player and leader, with the ability to work effectively and proactively alone and as part of cross-functional teams consisting of members from various levels within the organization.Focused on patient and customer and set high standards, instill operational excellence, and drive accountability.Excellent written, documentation, and oral communication skills and are fluent in English, both written and spoken. Distinguished organizational skills and can prioritize and work effectively on multiple projects. Medtronic offer a competitive salary and flexible Benefits Package #IJA