Senior Manufacturing Engineer

2 days ago

Limerick, Ireland Hero Recruitment Full time

Senior Manufacturing Engineer - Test Method Validation
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.
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