- Reference: 44438
- Job Type: Permanent
- Location: Dublin City Centre, Dublin South, Dublin West
- Category: Medical Devices
Immediate Position — Product Engineer required to join a leading Medical Devices organisation
The Senior Product Engineer would report to the R&D Manager responsible for leading and supporting the existing product line. The Senior Product Engineer’s primary role would be to provide support on a global basis for the Product Engineering working closely with product development, operations, manufacturing plants, and quality. It is critical that this candidate must be able to collaborate with manufacturing plants on a frequent basis to support the design modifications and improvements to product and process changes as required.
• Lead the design, development and verification of complex products and packaging throughout the development life cycle.
• Execute product engineering R&D which impact form/fit/function, line extensions, cost savings and compliance.
• 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.
• Oversee laboratory fit out through selection and purchase of new equipment.
• Design test equipment and create validated test procedures for product testing to demonstrate compliance with internal and external requirements such as ISO standards.
• Be responsible for supporting effective design and technology transfer from development to manufacturing by proactively working with stakeholders from manufacturing.
• 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 nonconformance issues with the products and identify creative solutions to problems in a timely manner to process NCMR, ACR, and CAPA documents.
• Augment and maintain robust design history files for the current diabetes products and line extensions.
• Plan and conduct ongoing competitive product analysis and device compatibility testing to provide key insights into the competitive landscape.
Experience and education
• Required is a bachelor’s degree in Engineering, preferably in Mechanical, Biomedical, or Chemical Engineering.
• Research post-graduate degree an advantage.
• Senior level 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.
• Leading device development teams throughout the product development lifecycle.
• Medical product design, research, and development.
• High volume manufacturing experience.
• Polymer material science and injection moulding processes.
• Sustaining engineering activities post launch.
• Tolerance analysis.
• 2D drawing generation, GD&T. 3D CAD modeling.
• Fixture creation & development and test method development, implementation and validation (Gage R&R) for medical device/systems.
• Statistical concepts such as those used in measurement system analysis, the design of experiments, and validation.
• The stage gate processes and design controls used in medical product development.
• Project planning and management of cross-functional teams
To apply please contact firstname.lastname@example.org or tel 09064 78104.