Manufacturing Engineer II

2 weeks ago

Athlone, County Westmeath, Ireland TN Ireland Full time
Job Overview

TN Ireland is seeking an experienced Manufacturing Engineer II to join our team in Medtronic Athlone. As a key member of our R&D Department, you will play a critical role in providing EU MDR compliance solutions and documentation throughout the project lifecycle.

About the Role

We are looking for a highly skilled and motivated individual to work with us on understanding and implementing EU MDR compliance solutions. In this role, you will coordinate and execute component and assembly validations according to agreed project schedules/timelines. You will also establish gaps in Project Validation Master Plans and Reports, IQ, OQ and PQ Plans and Reports. Furthermore, you will support the completion of risk management using tools such as Failure Modes Effect Analysis (FMEA), Fault Tree Analysis etc.

Responsibilities
  • 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;
  • Liaise with cross-functional team members, developing strong partnering relationships with these to establish inspection methods which ensure effective product acceptance activities;
  • Work with the R&D team to find novel solutions to problems and the opportunity to 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 a key skill;
  • Knowledgeable in Quality Systems, validation standards, statistical data analysis, policies, procedures, and methodologies;
  • 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.
Benefits

As a Manufacturing Engineer II at TN Ireland, you will be offered a competitive salary and flexible benefits package. Our company culture values what makes you unique and encourages innovation, collaboration, and continuous learning. Join us and take advantage of opportunities to grow your career and make a meaningful impact in the medical device industry.

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