Senior Engineer | Medical Device Company. The Senior Engineer provides leadership, support and Guidance to the project teams tasked with the development and transfers of new medical device products in compliance with applicable EU and FDA regulations. The senior engineer will take responsibility for several projects through the design & transfer cycle and will interface with R&D, clinical, quality, regulatory and operations teams. Location: Co. Galway. Pay/Benefits: Attractive Salary. Annual Bonus. VHI health Insurance for the employee (spouse and kids if applicable. Defined Contribution pension. Stock options grant available. Long term disability + Death in service cover up to 4x lump sum salary. Flexible working week (four days working week. Free car parking onsite. Canteen facilities onsite. Paid Holidays. Responsibilities of the Job: Provides technical leadership and support to the project teams in the process development, transfer, validations and subsequent commercialisation of products during the product lifecycle. Defines 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. Manages a small team of Engineers and Technicians within the Group. Mentor / Support Engineers through the design / transfer cycle requirements. Liaises 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. Supports & Facilitates customer correspondence for several key projects. Develops and implements programs in conjunction with Manufacturing Engineering, Operations and Quality Functions which drive a continuous improvement approach in the design for manufacture effectiveness. Manages development projects in compliance with approved procedures and in adherence to ISO and FDA regulations. What we would like you to have: 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. Is creative, continually stimulates his/her team to learn and explore new ideas. 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. Capacity to make sound judgements relating to the effective management of the company’s resources. Has a strong understanding and application of project management tools. Attention to detail while maintaining awareness of longer-term objectives. Strong interpersonal skills, a demonstrated ability to influence his/her peers. Displays the highest levels of integrity and diplomacy. Capacity to maintain the highest levels of confidentiality internally and externally. Acts in conjunction with his/her management peers as a champion of company values and standards. If you are interested in this job and are a suitably qualified and experienced Senior Engineer, please contact Aaron Long at Sigmar Recruitment T: +353 91 749 264 | E: email@example.com. 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.
241 days ago