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Senior NPI Engineer

Job description

Looking for a Senior NPI Engineer for a  Medical device company based in Co Galway. As well as offering excellent career opportunities and development, the company operates on a four day week..

Key responsibilities

  • Provide technical leadership and support to the project teams in the process development, transfer, validations and subsequent commercialisation of products during the product lifecycle
  • Define capacity and resource requirements, including recruitment, mentoring and development of the team to meet established project milestones.
  • Co-ordination of New Product Introduction (NPI) in the manufacturing plant including face-to-face meetings, teleconferences and regular updates on project activities, milestones, and status.
  • Development, execution and management of process validation activities.
  • Manage a small team of Engineers and Technicians within the Group.
  • Mentor / Support Engineers through the design / transfer cycle requirements,
  • Liaise with Business Development, Manufacturing & Quality to ensure that the transition of products through R&D, product approval and manufacturing scale up are smooth, timely and cost effective.
  • Support and  Facilitate customer correspondence for several key projects.
  • Manage development projects in compliance with approved procedures and in adherence to ISO and FDA regulations.

Key requirements:

  • Demonstrable Knowledge of medical device quality & regulatory systems and medical device directive (EN ISO13485, MDD and FDA CFR 820).
  • Ability to manage a high performing team to achieve desired outcomes.
  • A strong team player who builds and cultivates a winning culture though the team.
  • A good communicator who can easily convey his/her ideas and requirements across all levels in the organisation. Is comfortable and confident in presenting to customers or other external bodies.
  • Has a strong understanding and application of project management tools.
  • Attention to detail while maintaining awareness of longer-term objectives.

If you are interested in this Senior NPIEngineer role, please send your resume to mslevin@sigmar.ie or call me on 091 455 300 for more information.

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