Senior New Product Introduction Engineer – Galway
You will provide leadership to teams working on new medical device products in compliance with regulatory bodies.
- 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.
- 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