Senior Product/Process Development Engineer

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

• 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.