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Manufacturing Engineer II - EU MDR - 23 month contract - Medtronic Athlone, Athlone
Client: Medtronic
Location: Athlone, Ireland
Job Category: Other
EU work permit required: Yes
Job Reference: 19e11b9dd398
Job Views: 147
Posted: 21.01.2025
Expiry Date: 07.03.2025
Job Description:
Medtronic
At 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:
1. 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.
2. Work with the validation team to establish gaps in the Project Validation Master Plans and Reports, IQ, OQ and PQ Plans and Reports.
3. 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.
4. 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.
5. Ensure that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.
6. Suggest relevant changes to procedures and update standard operating procedures as necessary.
7. Liaise with cross-functional team members, developing strong partnering relationships to establish inspection methods which ensure effective product acceptance activities.
8. Work with the R&D team to find novel solutions to problems and develop innovative solutions.
Key Skills & Experience
1. Level 8 Degree in a relevant Quality/Engineering/Manufacturing related discipline.
2. Preferably with 3–5 years relevant experience in a medical devices or similar fast-paced regulated environment.
3. Knowledge of plastic processing techniques such as Extrusion, Injection Moulding, Blow Moulding, Assembly, etc.
4. Medical Device Process Validation experience is a key skill.
5. Knowledgeable in Quality Systems, validation standards, statistical data analysis, policies, procedures, and methodologies.
6. Skilled in the use of Solidworks or other 3D Modelling software is beneficial.
7. 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.
8. Focused on patient and customer, setting high standards, instilling operational excellence, and driving accountability.
9. Excellent written, documentation, and oral communication skills; fluent in English, both written and spoken.
10. Distinguished organizational skills and the ability to prioritize and work effectively on multiple projects.
Medtronic offers a competitive salary and flexible Benefits Package.
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