The Product Engineer will be responsible for sustaining medical device products. The role will involve working with Engineering, Operations, Quality and Regulatory teams to manage and execute R&D projects in support of different functions ensuring that activities are completed in compliance to ISO 13485 and 21 CFR 820 requirements. A hands-on approach to projects with a good attitude and work ethic is essential, with an ability to work in a cross functional, flexible and growing team. The role will be based at the ProVerum Manufacturing facility in Galway and will report to the Chief Technical Officer (CTO) or R&D Manager.
Role/Responsibilities:
Support Operations team in sustaining manufacturing line, by contributing to troubleshooting (real-time during builds, and through CAPA and NCR investigations).
Partner with Operations and Quality to design and optimise manufacturing processes, procedures, and production flow for assemblies.
Design, development, verification and implementation of process improvements and process aids/fixturing.
Assist with test and evaluation of new designs including process/product development, developing iterations of existing processes/products.
Owning CAPA, NC and SCAR process including conducting root cause analysis, implementation of corrective actions and executing verification of effectiveness.
Provide technical support to Suppliers of components and sub-assemblies to ensure reliability of supply, quality of product, optimization of manufacturing processes and process reliability throughout the supply chain.
Development and implementation of scale-up plans including a staged approach to reducing COGs.
Development of product packaging and packaging processes in conjunction with R&D.
Support production activities, change notices, calibrations, IQ, preventative maintenance etc.
Ensure that all products/ processes/ changes are developed in compliance with QMS and regulatory requirements for PMA and 510k approved products.
Maintain documentation for production, DHF, QMS procedures, validation protocols & reports.
Compile documentation to support product sustaining/ development activities in accordance with the Medical Device Directive (MDD) and ProVerum’s ISO 13485 Quality Management System - complete tasks including document control and writing protocols and test reports.
Skills/Experience:
The successful candidate should be degree qualified in a relevant Engineering or a related technical field and have the following skills and experience.
Minimum 3 years’ experience in medical device industry, preferably with exposure to manufacturing processes of electromechanical medical devices containing software.
Experience in product/ process validation and design verification/ validation.
Project planning and execution skills an advantage.
Excellent communication and writing skills.
Good mechanical design and understanding of engineering fundamentals with foundational knowledge of electronics and software being a strong advantage.
Good working knowledge of Solidworks or other CAD package.
Provide guidance, coaching, and training to other employees when required.
Knowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820) would be a distinct advantage.