Manufacturing Engineer (Senior or Level I/II)- Test Method ValidationLimerickContract Role - 2 - 3 yearsHybrid - 3 days onsiteAs a Manufacturing Engineer 2 (Test Method Validation), you will be responsible for ensuring that manufacturing processes meet the highest standards of quality, compliance, and efficiency. Your primary focus will be on developing and executing Test Method Validations (TMV) to ensure the reliability and accuracy of test equipment in a medical device manufacturing environment. You will work closely with cross-functional teams to validate processes, analyze data, and drive continuous improvement initiatives.Main ResponsibilitiesTest Method Validation : Develop, execute, and document TMVs for test equipment per QMS and regulatory standards.Process Validation: Support the validation and implementation of medical device manufacturing processes.Equipment & Fixture Qualification: Identify and establish IQ, OQ, PQ requirements for new and existing equipment.Process Characterization: Define acceptance criteria, analyze process outputs, and ensure compliance with industry standards.Verification Testing: Conduct and oversee testing to validate equipment performance and reliability.Documentation & Reporting: Prepare validation protocols, reports, and other technical documentation in compliance with regulatory and quality requirements.Project Management: Lead and contribute to validation projects, ensuring timely execution and collaboration across teams.Continuous Improvement: Identify and implement process enhancements to improve efficiency, compliance, and product quality.Stakeholder Collaboration: Work closely with Quality, R&D, and Manufacturing teams to align validation activities with business needs.Training & Development: Maintain all required training and proactively seek opportunities for professional growth.Leadership Support: Act as a deputy for the Senior Manufacturing Engineer (Test Method Validation) when required.Qualifications & ExperienceBachelor’s degree in Engineering or a related technical field (or equivalent relevant experience).Minimum 3 years of experience in validation (Test Method Validation or Product Validation preferred).Strong knowledge of medical device manufacturing, regulatory standards (ISO 13485, FDA, GMP), and validation best practices.Proficiency in statistical analysis, process characterization, and problem-solving methodologies.Excellent project management skills with the ability to handle multiple projects in a fast-paced environment.Strong interpersonal and communication skills to collaborate across teams and at all levels.Self-motivated team player with a strong work ethic and a passion for quality.High attention to detail and a proactive approach to problem-solving.For further information on this role in please contact on Emma Griffin on 086 0334325 or quality@hero.ieCheck out all our open jobs on our HERO Recruitment website – https://www.hero.ie/Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review
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