Process Development Engineer

2 weeks ago

Galway, Galway, Ireland beBeeDevelopment Full time €90,000 - €110,000
Job Description:

This role will be responsible for leading Process Development and Manufacturing Engineering activities. The ideal candidate will have a strong background in engineering, with experience in technical leadership roles within regulated environments.

The successful candidate will lead the development and implementation of manufacturing capabilities using LEAN principles and tools. This includes Value Stream Mapping, Poka-Yoke, Standard Work, Bottleneck Analysis, and Line Balance. They will also be responsible for working with Quality, managing NCMR's and CAPA's, supplier monitoring and audits, risk management, and internal controls while ensuring compliance with ISO 13485 and other relevant standards and regulations pertaining to medical device and pharmaceutical products.

Key Responsibilities:

  • Technical leadership of the manufacturing transfer of new products and changes to existing products
  • Develop and implement manufacturing capabilities using LEAN principles and tools
  • Responsible for working with Quality including management of NCMR's and CAPA's, supplier monitoring and audits, risk management and internal controls
  • Contribute to the successful execution of departmental and company goals

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