Senior Product/Process Development Engineer

1 week ago

Dublin, Dublin City, Ireland Life Science Recruitment Full time

Medical Devices – Senior Product/Process Development Engineer

Our client a medical device company who are developing a novel drug delivery system are currently seeking a Senior Engineer to join their team. to support product and process development activities from completion of concept feasibility to commercialisation. This is a great opportunity for an engineer looking to step into Senior Role from Engineer level

Role/Responsibilities:

· Development of Class III medical devices/processes, including the following o Drive product/process design and development to develop processes and supporting documentation for the neurological product portfolio Work on elements of product lifecycle from design verification through to commercialisation o Drive ongoing product and process improvements Development and validation of test and inspection methods (TMV/MSA) o Draft and execute equipment and process validation activities Applying lean principles, design/develop and introduce manufacturing processes for new products to meet the demands of productivity and quality (considering automation) To lead technical investigations and provide resolutions to a variety of technical problems with effective root cause analysis and implementation of effective corrective action Development of prototype devices based on outputs from the concept feasibility team Maintain high quality and compliance standards in line with the Renishaw QMS Generation and maintenance of manufacturing documentation (Manufacturing strategies, Process Flows, pFMEA, DMR, DHR) Support Production Builds for both Pre-Clinical and Clinical Trial including process verification activities after submission of clinical trial application. Maintain equipment in line with PM schedules Generation of IP Ensure all Health, Safety and Environmental requirements are fulfilled Skills/Experience:
Third level degree in Mechanical, Manufacturing or Production Eng or similar discipline Min. 4 years experience in product / process development, ideally in Class II / III medical devices Design Skills involving 3D modelling Experience designing jigs and fixtures and developing automated processes · Knowledge of materials and processing techniques (polymers, metals, ceramics), including rapid prototyping Knowledge of medical device quality & regulatory systems and medical device directive (ISO13485, MDD and FDA CFR 820). Experience of manufacturing processes within a clean-room environment Experience of risk assessment, particularly pFMEA Attention to detail and Quality Focus Strong communication skills Although not essential, it is desirable if applicants have the following: Knowledge of anatomy and physiology Experience of Lean manufacturing methodologies, DFM and 6-sigma desirable Ability to create new ideas and provide innovative solutions. For further information please contact james.cassidy@lifescience.ie or call in confidence 086 0204322

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