Looking for a Senior Engineer for a rapidly expanding Medical device company based in Co Galway.Aswellasofferingexcellentcareeropportunitiesanddevelopment,thecompanyoperatesonafourdayweek. TherolewillhaveastrongfocusonprojectsandNPI. 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. Supportand Facilitate customer correspondence for several key projects. Manage development projects in compliance with approved procedures and in adherence to ISO and FDA regulations. Keyrequirements: 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. IfyouareinterestedinthisSeniorEngineerrole,firstname.lastname@example.org. Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.
133 days ago