Senior New Product Introduction Engineer – Galway

You will provide leadership to teams working on new medical device products in compliance with regulatory bodies.

Responsibilities:

  • Provides technical leadership and support to the project teams.
  • Defines capacity and resource requirements, including recruitment, mentoring and development of the team.
  • Co-ordination of New Product Introduction (NPI) in the manufacturing plant. 
  • Development, execution and management of process validation activities.
  • Manages a small team of Engineers and Technicians within the Group.
  • Mentor engineers through the design / transfer cycle requirements.
  • Supports & facilitates customer correspondence for several key projects.
  • Develops and implements programs in conjunction with other teams to drive continuous improvement.
  • Manages development projects in compliance with approved procedures and in adherence to ISO and FDA regulations.

Requirements:

  • Demonstrable knowledge of medical device quality & regulatory systems and medical device directive (EN ISO13485, MDD and FDA CFR 820).
  • Knowledge of Stage-Gate process and/or Product Development life cycle.
  • Ability to manage a high performing team to achieve desired outcomes.
  • A strong team player who builds and cultivates a winning culture.
  • Has a strong understanding and application of project management tools.
  • Attention to detail while maintaining awareness of longer-term objectives.
  • Capacity to maintain the highest levels of confidentiality internally and externally.
  • Must be authorised to work in Ireland.

Please contact Emer Moore in confidence

+353578638188

emoore@emtechrecruitment.ie

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