The R&D 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.
• 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 commercialization.
• 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.
• 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 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.
• 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.
Clodagh Nerney | Tel: +353 (0) 1 507 9254