A respected medical device company are recruiting for a Product Engineer to join their R&D team in Dun Laoghaire.
As Product Engineer, you will;
• 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.
• 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.
The successful candidate will be educated to degree level in Engineering with Mechanical, Design, Biomedical being preferred. You will have experience with;
• Leading device development teams throughout the product development lifecycle
• Medical product design, research, and development.
• Familiarity of polymer material science and injection moulding processes.
• Sustaining engineering activities post launch.
• 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.
We are looking for passionate people who aren’t afraid to take smart risks, innovate and are eager to make things happen. This is an amazing opportunity to join a fast-growing company with room to grow your skills and experiences in a complex, matrix and international organization.
You can look forward to a rewarding career, great benefits package, collaborative working and opportunities to expand your skills in this fast moving, dynamic and agile business.
If you would like further Information you can contact the recruiter directly:
Claire Kenny | Tel: +353 (0) 1 507 9287