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Process Development Engineer II

Job description

Purpose

You will work closely with R&D and manufacturing in the development of next generation aortic valves focusing on the development of manufacturing processes, equipment, materials and products and support the efficient and effective transfer of new products & processes into commercial production

Responsibilities

  • You’ll be developing New Processes for this company’s aortic valve medical devices
  • You will liaise with equipment engineering or external equipment/tooling or material vendors in the selection, Design & Development of new (or upgrades to existing) Equipment, Tooling and Materials
  • You will lead the development and execution of experimentation and testing to enable characterisation, optimization and Troubleshooting of key processes and equipment
  • You will be responsible for Analysing and Drawing conclusions from test results leading to effective technical resolution
  • Co-ordinate the Introduction of New Processes, equipment and materials including installation, calibration, EHS assessment debug, and all associated process and quality system documentation requirements including technical and process work instructions
  • You will lead the writing and release of Process Validation Documentation including FMEA's, Validation Plans, protocols and reports
  • Supervise one or more Technicians, managing their technical development and facilitating their daily and project tasks

Requirements

  • Your Level 8 Degree in engineering or a related discipline
  • You’ll need strong Technical Expertise on process and product technologies to support validation and troubleshooting of said technologies
  • The ability to Mentor engineers and technicians in problem resolution
  • Strong knowledge of DMAIC tools
  • You’ll need experience with the application of Lean methodologies, and process improvement tools
  • Strong knowledge and application of process and equipment Validation Techniques, PFMEA’s, and associated regulatory requirements and applies this knowledge in the efficient & timely validation of equipment and processes.

Benefits

  • 10% Annual Bonus
  • Full Healthcare for you and Dependents
  • Contributory Pension (Up to 8%)
  • Early finish on a Friday
  • Life Assurance
  • Xmas Voucher

To apply for this position please contact Amanda Reynolds at Sigmar Recruitment T: +353 91 455304 E: areynolds@sigmar.ie

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