Senior Manufacturing Engineer

3 days ago


Limerick, 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. Connect@hero.ie

Senior Manufacturing Engineer (Test Method Validation)

Department: Manufacturing Engineering

Reporting to: Manager, Manufacturing Engineering

About the Role:

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.

Key Responsibilities:

  • Test Method Validation: 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.

Why Join Us?

  • Opportunity to work on cutting-edge medical device manufacturing processes.
  • Engage in high-impact validation projects that ensure patient safety and product quality.
  • Be part of a collaborative, innovative, and quality-driven engineering team.
  • Career growth opportunities with access to continuous development and training.
Seniority level
  • Mid-Senior level
Employment type
  • Full-time
Job function
  • Engineering, Management, and Product Management
  • Industries: Pharmaceutical Manufacturing and Medical Equipment Manufacturing
#J-18808-Ljbffr

  • Limerick, Limerick, Ireland Niras Ireland Full time

    Senior Manufacturing Engineer (Test Method Validation) NIRAS is currently recruiting for an experienced Senior Manufacturing Engineer (Test Method Validation) who will be based onsite at our client's advanced technology medical devices manufacturing facility in Limerick.As a member of our client's Manufacturing Engineering team, the Senior Manufacturing...


  • Limerick, Limerick, Ireland NIRAS Ireland Full time

    Senior Manufacturing Engineer (Test Method Validation)NIRAS is currently recruiting for an experienced Senior Manufacturing Engineer (Test Method Validation) who will be based onsite at our client's advanced technology medical devices manufacturing facility in Limerick. As a member of our client's Manufacturing Engineering team, the Senior Manufacturing...


  • Limerick, Limerick, Ireland HERO Recruitment Full time

    Senior Manufacturing Engineer (Test Method Validation) Location: Limerick Department: Manufacturing Engineering Reporting to: Manager, Manufacturing EngineeringAbout the Role: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...


  • 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 Digital Manufacturing Ireland Full time

    About UsDigital Manufacturing Ireland (DMI) is a newly established institute, led by the IDA, aimed at helping Irish-based manufacturers access and accelerate their adoption of digital technologies.We offer a world-class physical and digital factory, a vendor showcase, an industry collaboration space, and training facilities to support manufacturers in...


  • 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, 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, Limerick, Ireland Hero Recruitment Full time

    Job Description:The Senior Post-Market and Manufacturing Engineering Manager will be responsible for leading and inspiring teams across post-market and manufacturing engineering.Key responsibilities include driving operational excellence, fostering cross-functional collaboration, and championing continuous improvement initiatives.Key Skills and...


  • Limerick, Limerick, Ireland Hero Recruitment Full time

    About the Role:As a Senior Manufacturing Engineer (Test Method Validation), you will play a pivotal 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.


  • Limerick, Limerick, Ireland HERO Recruitment Full time

    About the RoleYou 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...


  • Limerick, Limerick, Ireland NIRAS Ireland Full time

    NIRAS is currently seeking a highly motivated Senior Manufacturing Engineer to join our client's advanced technology medical devices manufacturing facility in Limerick.This role will involve developing quality plans, managing new processes, and ensuring TMV closure for design and process functions.Key Responsibilities:Develop / Execute Test Method...


  • Limerick, Limerick, Ireland Hero Recruitment Full time

    Manufacturing Engineer II - Test Method ValidationAs 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...


  • Limerick, Limerick, Ireland Digital Manufacturing Ireland Full time

    Company Overview">The Digital Manufacturing Ireland (DMI) is a strategic government initiative that aims to support Irish-based manufacturers in adopting digital technologies.Our mission is to create a world-class physical and digital factory, a vendor showcase, an industry collaboration space, and training facilities to enhance, transform, and position...


  • 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

    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...


  • 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...