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.
#J-18808-Ljbffr



  • Limerick, Ireland Hero Recruitment Full time

    Get AI-powered advice on this job and more exclusive features.Direct message the job poster from HERO Recruitment Senior Recruitment Consultant at HERO Recruitment Ltd. Senior Manufacturing Engineer (Test Method Validation) Department: Manufacturing Engineering Reporting to: Manager, Manufacturing Engineering About the Role: As a Senior Manufacturing...


  • Limerick, Limerick, Ireland Hero Recruitment Full time

    Senior Manufacturing Engineer - Test Method ValidationAs 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...


  • Limerick, Limerick, Ireland Cook Medical Full time

    Overview The Senior Manufacturing Engineer (Test Method Validation) Reporting to: Manager, Manufacturing Engineering Responsibilities Develop and execute Test Method Validations for Test Equipment per current QMS/Regulataory standards. Validate and implement medical device manufacturing processes as assigned. Identify equipment/fixture installation...


  • Limerick, Limerick, Ireland Life Science Recruitment Full time

    Senior Manufacturing Engineer - (NC,CAPA,SICR)We're currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Limerick. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.DutiesDevelopment and implementation of appropriate supporting...


  • Limerick, Limerick, Ireland Cook Ireland Ltd Full time

    OverviewThe Senior Manufacturing Engineer (Test Method Validation)Reporting to: Manager, Manufacturing EngineeringResponsibilitiesDevelop and execute Test Method Validations for Test Equipment per current QMS/Regulatory standards.Validate and implement medical device manufacturing processes as assigned.Identify equipment/fixture installation qualification...


  • Limerick, Ireland Hero Recruitment Full time

    Senior Manufacturing Engineer - Test Method ValidationAs 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...


  • Limerick, Limerick, Ireland Life Science Recruitment Full time

    (Senior) Manufacturing Engineers - Global Medical DevicesMy client is a leading global medical devices innovator and manufacturer, currently seeking Manufacturing Engineers at all levels for their state of the art Limerick facility.You will join a fast-paced, innovative, and progressive team where career progression is a pivotal part of the company...


  • Limerick, Ireland Life Science Recruitment Full time

    (Senior) Manufacturing Engineers - Global Medical Devices My client is a leading global medical devices innovator and manufacturer, currently seeking Manufacturing Engineers at all levels for their state of the art Limerick facility. You will join a fast-paced, innovative, and progressive team where career progression is a pivotal part of the company...


  • Limerick, Ireland Life Science Recruitment Full time

    (Senior) Manufacturing Engineers - Global Medical DevicesMy client is a leading global medical devices innovator and manufacturer, currently seeking Manufacturing Engineers at all levels for their state of the art Limerick facility.You will join a fast-paced, innovative, and progressive team where career progression is a pivotal part of the company...


  • Limerick, Ireland Cook Medical Incorporated Full time

    OverviewThe Senior Manufacturing Engineer (Test Method Validation)Reporting to: Manager, Manufacturing EngineeringResponsibilitiesDevelop and execute Test Method Validations for Test Equipment per current QMS/Regulatory standards.Validate and implement medical device manufacturing processes as assigned.Identify equipment/fixture installation qualification...


  • Limerick, Ireland Cook Medical Full time

    Overview The Senior Manufacturing Engineer (Test Method Validation) Reporting to: Manager, Manufacturing Engineering Responsibilities Develop and execute Test Method Validations for Test Equipment per current QMS/Regulataory standards. Validate and implement medical device manufacturing processes as assigned. Identify equipment/fixture installation...


  • Limerick, Ireland Cook Medical Incorporated Full time

    Overview The Senior Manufacturing Engineer (Test Method Validation) Reporting to: Manager, Manufacturing Engineering Responsibilities Develop and execute Test Method Validations for Test Equipment per current QMS/Regulatory standards.Validate and implement medical device manufacturing processes as assigned.Identify equipment/fixture installation...


  • Limerick, Limerick, Ireland Edwards Lifescience Ireland Ltd Full time

    Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients' lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us...


  • Limerick, Ireland Edwards Lifescience Ireland Ltd Full time

    Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients' lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us...


  • Limerick, Ireland Edwards Lifescience Ireland Ltd Full time

    Make a meaningful difference to patients around the world.At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients' lives.As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn...


  • Limerick, Ireland Edwards Lifesciences Full time

    Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us...


  • Limerick, Limerick, Ireland Edwards Lifescience Ireland Ltd Full time

    Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients' lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us...


  • Limerick, Limerick, Ireland Cook Medical Full time

    Overview The Manufacturing Engineer 2 (Test Method Validation) Reporting to: Manager, Manufacturing Engineering Responsibilities Develop and execute Test Method Validations for Test Equipment per current QMS/Regulatory standards. Validate and implement medical device manufacturing processes as assigned. Identify equipment/fixture installation qualification...


  • Limerick, Limerick, Ireland Digital Manufacturing Ireland Full time

    As part of a government-led initiative spearheaded by the IDA, Digital Manufacturing Ireland (DMI) provides a cutting-edge environment to help Irish-based manufacturers (including MNCs and SMEs) integrate advanced digital technologies.DMI offers a state-of-the-art physical and digital factory, a vendor showcase, industry collaboration spaces, and training...


  • Limerick, Ireland Digital Manufacturing Ireland Full time

    A Strategic Government Initiative, led by the IDA, the DMI is a newly established institute which is intended to help Irish based manufacturers (MNC's and SME's) to access and accelerate their adoption of digital technologies.Offering a world class physical and digital factory, a vendor showcase, an industry collaboration space, and training facilities the...