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James Cassidy
Life Science

+353 1 5079250
[email protected]
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Details

Senior Product/Process Development Engineer


Reference:JCAO2212 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Snr R and D 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


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 [email protected] or call in confidence 086 0204322