Mechanical Engineer

We are looking for aSr Mechanical Engineersfor a venture-backed Irish medical device developer.Our client is now seeking to expand its engineering department to work on software and hardware development for current and new medical device products that combine neuromodulation, wireless communications and physiological sensing technologies and to support ongoing product design validation and production process validation activities.Responsibilities:Work closely with project Lead and Product Development team to develop, build and test next generation medical devices.Support product development from concept generation through to post-production.Support design and technology transfer from product development to manufacturing by proactively working with stakeholders from manufacturing and quality.Leading process development and process validation activities, including IQ, OQ & PQ.Provide support to Manufacturing to facilitate efficient operations within the production area, to optimise existing processes and to ensure that production goals are met.Oversee the analysis of hardware failures from the field and participate in associated corrective and preventive actions.Participation in the drafting of test protocols may be required, in addition to documenting test results and generating test reports. Testing may include mechanical, electrical, performance, user interface / usability and software.Qualifications and Experience:Degree in Mechanical Engineering, Manufacturing Engineering or similar discipline with 5+ years' medical device industry experience in a product development or manufacturing role.Product design and development experience, including experience in design review, risk management and quality procedures.Proficient in using Solid Works, Inventor or equivalent 3D CAD design package.PC Literate (word processing, spreadsheets, data base) and a good knowledge of project Management tools.A good understanding of quality management system principles (e.g. ISO 9001 or ISO 13485) and/or FDA quality system regulation processes according to 21 CFR part 820.Any applicant must be eligible to work in Ireland. Existing work permit or EU passport required.No visa sponsorship will be offered with this role.Call Ruth on 087 7822 198 or email ruth.holland@lifescience.ie for more details.