Senior R&D Design Engineer (Medical Devices)
Job Description Summary
Our client, a reputable medical device market leader is looking for a highly talented Senior Design Development Engineer who will provide support on a global basis for Diabetes Care Product Engineering working closely with advanced diabetes care, operations, manufacturing plants and quality. You will collaborate with manufacturing plants on a frequent basis to support the design transfer of highly complex diabetes care products. As part of an expanding team you will have excellent opportunities to broaden your knowledge and develop your career within an exciting Global business.
Be the Senior Design Development Engineer:
• Design, develop and verify complex products and packaging throughout the development life cycle.
• Design for high volume manufacturing for electro mechanical medical devices.
• Support effective design and technology transfer from development to manufacturing by proactively working with stakeholders from manufacturing.
• Execute product engineering R&D which impact form/fit/function, line extensions, cost savings and compliance.
• Lead structured problem solving and root cause investigations.
• Use predictive design and tolerance analysis techniques for calculation of design specifications.
• Lead the evaluation of specifications for the current diabetes products and generate the necessary supporting data to support/enhance these specifications.
• Develop and test prototypes.
• Design test equipment and create validated test procedures for product testing to demonstrate compliance with internal and external requirements such as ISO standards.
• Provide critical support to the Quality function, and the worldwide Regulatory Affairs function to enable continued / new business opportunities, including new product registrations, in all parts of the world.
• Collaborate with manufacturing plants to assist in non-conformance issues with the products and identify creative solutions to problems in a timely manner to process NCMR, ACR, and CAPA documents.
• You will have a bachelor’s degree in Engineering, preferably in Mechanical, Biomedical, or Chemical Engineering.
• You will have experience leading small-medium size engineering teams.
• You will have experience with microfluidics / pump design.
• You will have experience in the design of complex electro-mechanical devices.
• Research post-graduate degree is also an advantage.
• You will have 7+ years’ experience in medical device design or R&D with a successful track record of delivering products to market and successfully supporting products in the market after launch.
• Ideally from a high volume manufacturing background.
• Knowledge of polymer material science and injection moulding processes and sustaining engineering activities post launch.
• You will have experience with Tolerance analysis. 2D drawing generation, GD&T and 3D CAD modelling.
• Statistical concepts such as those used in measurement system analysis, the design of experiments, and validation.
• You will be familiar with the stage gate processes and design controls used in medical product development and project planning and management of cross-functional teams.
If you would like further Information you can contact the recruiter directly:
Claire Kenny | Tel: +353 (0) 1 507 9287