Manufacturing Engineer II ( Test Method Validation )

Hero Recruitment

  • Limerick
  • Temporary
  • Full-time
  • 2 months ago
As a Senior Manufacturing Engineer (Test Method Validation), you will play a critical role in ensuring robust, compliant, and efficient manufacturing processes for medical devices. Your primary focus will be on developing, executing, and managing Test Method Validations to meet stringent quality and regulatory standards. You will work cross-functionally with design, process, and quality teams to validate and implement manufacturing processes while driving continuous improvement initiatives.Main Responsibilities
  • Test Method Validation (TMV): Develop and execute TMVs for test equipment, ensuring compliance with QMS and regulatory standards.
  • Process Validation: Validate and implement medical device manufacturing processes, ensuring efficiency and regulatory adherence.
  • Equipment & Fixture Qualification: Identify and establish installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) requirements.
  • Process Characterization: Define acceptance criteria, analyze process outputs, and ensure data integrity.
  • Documentation & Reporting: Prepare and maintain validation protocols, reports, and supporting documentation per regulatory and quality requirements.
  • Verification Testing: Conduct and oversee verification testing to ensure compliance and reliability.
  • Project Management: Lead and execute validation projects, ensuring timely delivery while coordinating across functions.
  • Stakeholder Collaboration: Work closely with Quality, R&D, and Manufacturing teams to align validation activities with business needs.
  • Leadership & Mentorship: Act as a delegate for the Manufacturing Engineering Manager and Senior Test Engineer, while supporting junior engineers.
  • Continuous Improvement: Identify and drive process enhancements to improve efficiency, compliance, and product reliability.
Qualifications & Experience
  • Bachelor’s degree in Engineering or a related technical field (or equivalent relevant experience).
  • Minimum 5 years of experience in validation (Test Method Validation or Product Validation preferred).
  • Strong knowledge of medical device manufacturing, regulatory standards (FDA, ISO 13485), and validation best practices.
  • Proficiency in statistical analysis, data-driven decision-making, and problem-solving.
Excellent project management skills with the ability to lead multiple projects simultaneously. * 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.
  • Ability to work in a fast-paced, regulated environment while maintaining attention to detail.
For further information on this role in please contact on Gavin Moran on 087 4108620 or connect@hero.ieCheck out all our open jobs on our HERO Recruitment website –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

Hero Recruitment