Senior Process Development Engineer

Our client, an established start-up in the medical device sector, is seeking a Senior Process Development Engineer to join their R&D team. Reporting to the CTO, the candidate will collaborate with Operations, Quality and Regulatory departments to transfer, implement, validate and scale up manufacturing processes within the facility and oversee sub‑contract manufacturing partners during production and validation activities.

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• 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
  

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• 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 xcfaprz 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 or call in confidence