Product Engineer - South Dublin.
In this role you will join an existing and growing R&D team.
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 current 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 non-conformance 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 products and line extensions.
Plan and conduct ongoing competitive product analysis and device compatibility testing to provide key insights into the competitive landscape.
Interested candidates should be educated to degree level in Engineering with Mechanical, Design, Biomedical being preferred. You will have experience with:
Medical product design, research, and development.
Familiarity with 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 (Gauge 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.