Product Engineer

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.