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James Cassidy
Life Science

+353 1 5079250
[email protected]
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Details

Senior R&D Engineer


Reference:JCAO1608 Location: Galway
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Product Development Engineer, Senior Research and Development Engineer

Senior R&D Engineer

Our client an established and high potential start up medical device start up currently seeking a a Senior R&D Engineer to join their team. Reporting to the CTO the Senior R&D Engineer will hold a key role within the R&D team and work in collaboration with Operations, Quality and Regulatory teams to transfer, implement, validate and scale up manufacturing processes within the manufacturing facility. In addition, the Senior R&D Engineer will provide oversight of sub‐contract manufacturing partners during routine production, scale up and validation activities.

Role/Responsibilities:

  • Design and conduct engineering bench testing as required to investigate and develop appropriate manufacturing processes and specifications
  • Ensure process design and specifications are robust, reproducible and capable of meeting all qualification requirements
  • Plan, develop and execute test methods for process qualification (validation) testing of manufacturing processes
  • Manage sub contract manufacturing partners through process qualification (validation) testing and through manufacturing scale up activities
  • Support and lead CAPA and NCR investigations from internal manufacturing and sub contract manufacturing processes
  • Provide guidance to R&D Engineers, Technicians and Product Builders
  • Compile technical documentation to support product development in accordance with ISO 13485 Quality Management System
Skills/Experience
  • Minimum level 8 degree in Engineering, or related technical field
  • At least 5 years previous related experience in the medical device industry
  • Experience in product development and process validation processes
  • Excellent knowledge of catheter technologies including manufacturing of reinforced (braided and coiled), steerable polymer shafts
  • Demonstrated analytical problem‐solving abilities
  • Good working knowledge of medical device materials and processes
  • Good working knowledge of Microsoft Office including MS Project or similar
  • Strong interpersonal and organizational skills and the ability to work effectively as a team member


For further information please contact James Cassidy at [email protected] or call in confidence +353 86 020433