Manufacturing Process Engineer

16 hours ago

Galway, Galway, Ireland beBeeProcess Full time €60,000 - €80,000

Process Development Specialist

We are seeking a skilled and experienced Process Development Specialist to join our team. Reporting to the CTO, you will hold a key role within the R&D department and work in collaboration with Operations, Quality Assurance and Regulatory teams to transfer, implement, validate and scale up manufacturing processes within the manufacturing facility.

Key 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
Requirements:
  • 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

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