Manufacturing Engineer

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  • Job type:

    Full Time

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  • Published:

    24 days ago

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  • Consultant:

    Emma Ryan

Job description

About Your New Employer

As an outsource partner to several of the world's premier medical device businesses, my client in Spiddal designs, develops, and manufactures implanted medical devices.

Their focus on cutting-edge technology and biomaterials knowledge fosters a vibrant culture that produces next-generation implantable solutions.

About Your New Job

  • Provide high-value support to their manufacturing operations through daily collaboration with production staff and Manufacturing Engineer supervisors, working with cross-functional colleagues to resolve production floor issues.
  • Identify and implement manufacturing projects which improve product quality, reduce lead times, and reduce costs.
  • Deploy the principles of lean and six sigma in identifying and implementing the optimum areas for improvement in manufacturing operations.
  • Assist New Product Introduction (NPI) teams with key input into design for-manufacturing and product flow/layout development. Take ownership for the execution of process qualification related builds.
  • Key member of PFMEA-generation workshops.
  • Ownership of IQ, OQ, PQ protocol-generation, execution, and reporting.
  • Maintain, update and review manufacturing, quality and engineering related documentation as required – driving and reviewing all Engineering Change Notice (ECN) proposals.
  • Assist with training of product builder staff on key operational tasks.
  • Enjoy a multi-departmental approach to problem-solving.
  • Perform facility-based EH&S, layout or energy-savings projects as required.
  • Overseeing the maintenance and calibration of critical equipment systems.
  • There will be a strong linkage with the Quality Assurance department in supporting the Regulatory and Compliance requirements of an ISO13485 organisation. This will encompass NCR and CAPA ownership and resolution.
  • Make appropriate decisions daily, using the Manufacturing Manager and Senior Quality Assurance representatives as needed as the final arbitrators on critical quality-related decisions.
  • Performs other related duties, as assigned.

What Skills You Need

  • Successful candidate must have a strong track record of execution within in a medical device environment. This role will involve production-support of Tier1-multinational-customer products – and as such, experience is essential.
  • A Bachelor’s degree in manufacturing engineering, biomedical engineering, quality engineering, or related field and 3 years’ minimum experience is required.
  • Experience in the areas of medical textile technologies (such as polymer/wire-braiding, weaving, knitting etc) and polymer coating/grafting technologies is desirable.
  • Strong familiarity with FDA GMP/QSR; ISO 13485 and medical standards is required.
  • Experience of transferring products from design into commercial manufacturing, is highly desirable
  • Solid knowledge of PFMEA development, IQ/OQ/PQ validation is required.
  • Candidate must be highly motivated and passionate about meeting production targets with excellent time-management, presentation, communication skills, technical writing skills and organizational skills with the ability to work independently or as part of a team.
  • Possess strong analytical skills, with a hands-on approach.
  • Project management experience is desirable

What’s on Offer

  • Competitive salary
  • Healthcare
  • Pension
  • Career progression

What’s Next​

Apply now by clicking the “Apply Now" button or call me, Emma Ryan on (086) 440 5143 Or if the job isn’t quite right but you are looking for something similar, please get in touch

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