Job Description
Medtronic seeks a highly skilled EU MDR Manufacturing Engineer to join their R&D Department in Athlone, Ireland.
**Job Summary:** EU MDR Manufacturing Engineer will lead the development of EU MDR compliance solutions and documentation throughout the project lifecycle, ensuring continuous improvement of manufacturing processes, systems, quality, and regulatory compliance to the highest standards.
**A Day in the Life:** As part of the EU MDR compliance project, the successful candidate will work with manufacturing and validation engineers to coordinate and execute component and assembly validations according to agreed project schedules/timelines. Key responsibilities include:
- Establishing gaps in Project Validation Master Plans and Reports, IQ, OQ, and PQ Plans and Reports
- Supporting the completion of risk management using tools such as Failure Modes Effect Analysis (FMEA) and Fault Tree Analysis
- Designing or specifying inspection and testing mechanisms and equipment, conducting quality assurance tests, and performing statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications
- Liaising with cross-functional team members to establish inspection methods that ensure effective product acceptance activities
- Working with the R&D team to find novel solutions to problems and develop innovative solutions
**Key Skills and Experience:** * Level 8 Degree in a relevant Quality/Engineering/Manufacturing related discipline * 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 * Knowledgeable in Quality Systems, validation standards, statistical data analysis, policies, procedures, and methodologies * Skilled in the use of Solidworks or other 3D Modelling software * Dynamic team player and leader, with the ability to work effectively and proactively alone and as part of cross-functional teams * Excellent written, documentation, and oral communication skills and fluency in English, both written and spoken * Distinguished organizational skills and ability to prioritize and work effectively on multiple projects
**About Medtronic:** Medtronic is a global healthcare technology leader that boldly attacks the most challenging health problems facing humanity. Our mission is to alleviate pain, restore health, and extend life. We are engineers at heart, putting ambitious ideas to work to generate real solutions for real people.