R&D Development Engineer (Medical Device
R&D Development Engineer- County Galway. In this role you will work as part of the R&D team tasked with the development of new medical device products in compliance with applicable regulations including EU and FDA regulations. Core Responsibilities. • Develop Products and corresponding processes which meet the customer requirements throughout the design phase. • Generate technical documentation for the Product Design History File and Device Master Records. • Develop test methods for product evaluation and validation. Develop and execute test method validations. • Liaise where necessary with Business Development and Physicians to understand and validate the specific market requirements in any given product segment. • Partner with Manufacturing Engineering, Quality and Operations to ensure that the transition of products through R&D, product approval and manufacturing scale up are smooth, timely and cost effective. • Support Manufacturing post product commercialisation. • As part of the R&D team, contribute effectively to the broader technical and resource needs of the team while ensuring specific technical expertise is continually developed and strengthened. Qualifications and Experience Sought: An Engineering or Science Degree. A minimum of 4 years' post-qualification experience within a Medical Device environment, with at least two spent in the R&D Dept. Demonstrable detailed working knowledge of the medical device industry. A good knowledge of design life cycles requirements. An analytical approach to problem solving. Is creative, continually learning and exploring new ideas. Good understanding and application of project management tools. Effective knowledge of the regulatory environment in which the business operates. This job originally appeared on RecruitIreland.com.
103 days ago