Manufacturing Engineer

Manufacturing Engineer Level II- Test Method Validation

• Limerick
• Contract Role - 2 - 3 years
• Hybrid - 3 days onsite

As 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 Responsibilities

• Test 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.

Qualifications & Experience

• Bachelor’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.