Job Description
**EU MDR Manufacturing Engineer**
Medtronic is seeking a highly skilled EU MDR Manufacturing Engineer to join our R&D Department in Athlone. As a key member of our team, you will be responsible for providing EU MDR compliance solutions and documentation throughout the project lifecycle.
**Key Responsibilities:**
- Coordinate and execute component and assembly validations according to agreed project schedules/timelines.
- Work with the validation team to establish gaps in the Project Validation Master Plans and Reports, IQ, OQ and PQ Plans and Reports.
- Support the completion of risk management, including the use of tools such as Failure Modes Effect Analysis (FMEA), Fault Tree Analysis, etc.
- Design or specify inspection and testing mechanisms and equipment; conduct quality assurance tests; and perform statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
- Liaise with cross-functional team members to establish inspection methods which ensure effective product acceptance activities.
- Work with the R&D team to find novel solutions to problems and develop innovative solutions.
**Requirements:**
- 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 is 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.
**About Medtronic:**
Medtronic is a global leader in healthcare technology, boldly attacking 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.
**Benefits and Compensation:**
Medtronic offers a competitive salary and flexible benefits package. We recognize the contributions of our employees and share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.