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NPI Engineer

  • Location: Galway, County Galway, Connaught, Ireland
  • Job Type:Permanent
  • Sector: Engineering
  • Contact: Rhys Joyce
  • Job Ref: 17449

My client, an expanding Medical Device Company just outside Galway City, is looking to hire an NPI Engineer to their growing team. The position requires a proven candidate with a background in the commercial transfer of innovative product designs within a GMP/FDA/ISO regulated medical devices industry.


Duties and Responsibilities

  • Contribute to the New Product Introduction (NPI) teams with key input into

    • Scaling, development, and validation of product, and packaging.

    • Equipment procurement and facility layout.

    • Initial capacity planning and identifying production operator needs.

    • Development of production and Quality procedures.

    • Material sourcing and procurement including supplier qualification input

    • Design-for-manufacturing and product flow/layout development.

  • Take ownership for the execution of process qualification related builds and testing.

  • Ownership of IQ, OQ, PQ protocol-generation, execution and reporting.

  • Initiate, maintain, update and review manufacturing, quality and engineering-related documentation as required – driving and reviewing Engineering Change Notice (ECN) proposals.

  • Assist with training of product builder staff on key operational tasks.

  • Perform facility-based EH&S, layout or energy-savings projects as required.

  • Coordinate and manage teams in meeting internal and external (customer) quality, timeline and budget commitment in transferring product and packaging designs into fully qualified commercial manufacturing processes.

  • Deploy the principles of lean and six-sigma in identifying and implementing the optimum areas for improvement in manufacturing operations.

  • There will be a strong linkage with the Quality Assurance department in supporting the Regulatory and Compliance requirements of an ISO13485 organisation.

  • Make appropriate decisions on a daily basis, using the NPI Manager and Senior Engineering (NPI, Operations, Quality) representatives as needed.

Key Requirements

  • Reporting to the NPI Manager the successful candidate must have a track record of success in a manufacturing environment for a medical device company, a degree in Engineering or related field and 3 years of experience in a medical device engineering role.

  • Candidate must be highly motivated and passionate about developing new products with strong documentation, oral, and interpersonal communication skills required.

  • The individual must be proficient in Medical Device design principles and material selection with a knowledge of FMEA, TMV, MVP, IQ/OQ/PQ and software validation.

  • Possess strong analytical skills, with a hands-on approach. Project management experience is desirable.

For a confidential discussion and more information on the role please contact Rhys Joyce.

091-706718

rhys.joyce@collinsmcnicholas.ie