Senior Manufacturing Engineer

2 weeks ago


Limerick, 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

1. Test Method Validation (TMV): Develop and execute TMVs for test equipment, ensuring compliance with QMS and regulatory standards.
2. Process Validation: Validate and implement medical device manufacturing processes, ensuring efficiency and regulatory adherence.
3. Equipment & Fixture Qualification: Identify and establish installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) requirements.
4. Process Characterization: Define acceptance criteria, analyze process outputs, and ensure data integrity.
5. Documentation & Reporting: Prepare and maintain validation protocols, reports, and supporting documentation per regulatory and quality requirements.
6. Verification Testing: Conduct and oversee verification testing to ensure compliance and reliability.
7. Project Management: Lead and execute validation projects, ensuring timely delivery while coordinating across functions.
8. Stakeholder Collaboration: Work closely with Quality, R&D, and Manufacturing teams to align validation activities with business needs.
9. Leadership & Mentorship: Act as a delegate for the Manufacturing Engineering Manager and Senior Test Engineer, while supporting junior engineers.
10. Continuous Improvement: Identify and drive process enhancements to improve efficiency, compliance, and product reliability.

Qualifications & Experience

1. Bachelor's degree in Engineering or a related technical field (or equivalent relevant experience).
2. Minimum 5 years of experience in validation (Test Method Validation or Product Validation preferred).
3. Strong knowledge of medical device manufacturing, regulatory standards (FDA, ISO 13485), and validation best practices.
4. Proficiency in statistical analysis, data-driven decision-making, and problem-solving.
5. Excellent project management skills with the ability to lead multiple projects simultaneously.
6. Strong interpersonal and communication skills to collaborate across teams and at all levels.
7. Self-motivated team player with a strong work ethic and a passion for quality.
8. Ability to work in a fast-paced, regulated environment while maintaining attention to detail.

#J-18808-Ljbffr

  • 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, 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 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 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, 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...

  • Manufacturing Lead

    1 day ago


    Limerick, Limerick, Ireland Pale Blue DotRecruitment Limited Full time

    Direct message the job poster from Pale Blue Dot Recruitment LimitedSenior Recruitment Consultant - Specialist in MedTechOur client, a medical device engineering company based in Limerick who specialize in manufacturing precision components are seeking a Additive Manufacturing Lead to join their team.The ideal candidate possesses both a high level of...


  • Limerick, Limerick, Ireland Edwards Lifesciences Gruppe Full time

    Senior Director, ManufacturingLocation: Ireland-Limerick, Ireland-ShannonTime Type: Full timePosted on: Posted YesterdayJob Requisition ID: Req-36920Manage team to ensure smooth and continuous operations in manufacturing.How Will You Make An Impact?- Direct team members and manufacturing activities with overall responsibility of developing systems, planning,...

  • Senior Engineer

    2 weeks ago


    Limerick, Limerick, Ireland Stryker Corporation Full time

    Stryker Corporation To apply for this position please CLICK HERE Why engineering at Stryker? At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare...


  • Limerick, Limerick, Ireland Cook Medical Full time

    Overview ​​The Manufacturing Engineering Specialist is responsible for the preventative maintenance schedule of equipment used in production and engineering. This also includes maintaining a database and all related documentation.​ Reporting to: Manager, Manufacturing Engineering Responsibilities ​​Maintain and implement the daily...


  • Limerick, Limerick, Ireland Stryker Group Full time

    Job TitleSenior Engineer, Process OptimisationReports ToManager / Senior Manager, Automation / EngineeringPosition SummaryProvides technical oversight and leadership for a specific process, project, or function. Knows and applies fundamental Engineering principles throughout the course of their duties.Key Areas of Responsibility1. Lead the process...

  • Lean Manufacturing

    3 weeks ago


    Limerick, Limerick, Ireland Pale Blue Dot Recruitment Full time

    Lean Manufacturing & Continuous Improvement LeadWe are seeking a skilled Lean Manufacturing & Continuous Improvement Lead to join our client, a medical device engineering company based in Limerick.The ideal candidate will have a strong technical background in CNC machining and mechanical engineering, with a hands-on approach to problem-solving.Key...

  • Senior MES Engineer

    2 weeks ago


    Limerick, Limerick, Ireland Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...


  • Limerick, Limerick, Ireland Stryker Group Full time

    Job TitleSenior Staff Engineer, Process OptimisationReports ToManager / Senior Manager, Automation / EngineeringPosition SummaryThe senior staff engineer will provide technical leadership across a range of projects and initiatives for the facility. They will be a Subject Matter Expert in a Technical, Engineering, Automation or Business Process area.Key Areas...

  • Lean Manufacturing

    2 weeks ago


    Limerick, Limerick, Ireland Pale Blue Dot Recruitment Full time

    Lean Manufacturing & Continuous Improvement Lead- On-site- Limerick , Munster , Ireland- Engineering ( Production/Process Dev/Manufacturing)Our client, a medical device engineering company based in Limerick who specialize in manufacturing precision components are seeking a Lean Manufacturing & Continuous Improvement Lead to join their team.The ideal...


  • Limerick, Limerick, Ireland Lilly Full time

    We're looking for people who are determined to make life better for people around the world. Position Title: IT Manufacturing Professional - Logistics/Supply Chain Reporting To: Senior Director - Manufacturing & Quality IT Lilly is currently constructing a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland. This...


  • Limerick, Limerick, Ireland Cregg Group Full time

    CREGG is currently seeking aManufacturing Technicianon a Swing Shift basisfor our client based in Annacotty, Co. Limerick. Our client is a global medical technology company specialising in devices that enhance patient care. This client partners with customers to design and manufacture custom medical components and devices, offering expertise in design,...