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Senior Product Engineer

Reference:AEGS-416254
Location: Dublin
Qualification:Degree
Experience:5-7 Years
Job Type:Permanent
Salary:Not Disclosed
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Senior Product Engineer
Our client, a global medical device organisation requires a Senior Product Engineer to join their team on a permanent basis. The Senior Product Engineer will report directly into the R&D Manager and will also work closely with product development, operations, manufacturing plants, and quality teams.

Responsibilities
• 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 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 diabetes products and line extensions
• Plan and conduct ongoing competitive product analysis and device compatibility testing to provide key insights into the competitive landscape

Requirements
• 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 modelling
• 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


If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252




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