R&D Engineer
CPL
Galway
A growing medical device company in Co. Galway is looking for a R&D Engineer. Reports to: R&D Manager. Overview: The R&D Catheter Development Engineer works as parts of the R&D team tasked with the development of new medical device products in compliance with applicable regulations including EU and FDA regulations. Responsibilities: Develop Products and corresponding processes which meet the customer requirements throughout the design phase. Ensuring the product & processes are designed efficiently to ensure commercial success. Generate technical documentation for the Product Design History File and Device Master Records. Establish and maintain appropriate Manufacturing documentation including, Equipment documentation, Bills of Materials, Product routings, Manufacturing procedures and Logs. Develop and execute required validations in line with regulatory requirements to include Equipment, Process & Product validations. Develop test methods for product evaluation and validation. Develop and execute test method validations. Liaise with project leads to understand product development requirements and processes associated with new product design. 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. 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 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. Competencies and Attributes. Demonstrable good knowledge of catheter development. A good knowledge of design life cycles requirements. An analytical approach to problem solving. Is creative, continually learning and exploring new ideas. A self starter, applies his/her own initiative in most situations. A good team player who works well in a small team environment. A good communicator who can easily convey his/her ideas and requirements across all levels in the organisation. Capacity to make sound judgements while learning from mistakes. Good understanding and application of project management tools. Effective knowledge of the regulatory environment in which the business operates. 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. Capacity to maintain the highest levels of confidentiality internally and externally. They are offering a competitive salary and excellent benefits package. If you are interested in applying please send your CV to rebecca.meaney@cpl.ie or call me on +35391507509 for more information. This job originally appeared on RecruitIreland.com.
2495 days ago