Advanced Manufacturing Professional

2 weeks ago

Galway, Galway, Ireland beBeeProcess Full time €80,000 - €150,000
Senior Process Development Engineer Opportunity

This is a 12-month contract role. As a Senior Process Development Engineer, you will be a core member of a cross-functional team responsible for developing and delivering complex acute ischemic stroke projects with significant technical challenges from initial concept through to commercialization.

The candidate's primary responsibility will be to work with the product development team, suppliers of raw materials, and suppliers of manufactured assemblies, from individual components to final packaged, sterilized devices.

The role will be involved throughout the entire product and process development cycle from initial prototyping through to process validation and commercialization.

The key goals will be to ensure that optimal materials, suppliers, and manufacturing processes are selected and developed to deliver a high-quality, capable, right-first-time product output at maximum yields and efficiencies to achieve/exceed manufacturing quality and cost targets.

Key Responsibilities:
  • Work collaboratively on cross-functional project teams to develop robust product design to ensure capable manufacturing processes (Design for Manufacture).
  • Evaluate critical-to-quality requirements for components used to build complex acute ischemic stroke devices and translate these requirements into component specifications that ensure components are manufacturable and performance is maintained consistently.
  • Assess new and existing raw materials, component, and assembly suppliers for technical and manufacturing capabilities.
  • Drive process/product improvements (design for manufacture/design for assembly) related to sub-assembly or component usage or design.
  • Manage prototype builds to support characterization and develop assessment strategies.
  • Develop strategies to characterize and validate new and improved manufacturing processes and components on external supplier manufacturing line and pilot lines.
  • Collaborate with suppliers and incoming inspection laboratories to develop, validate, and ensure appropriate inspection methods and controls are in place for components and finished devices.
  • Identify project risks and develop mitigation strategies to ensure supply, quality, and timelines are met.
  • Monitor supplier performance and provide technical support to resolve issues.
  • Implement changes under the Cerenovus change management system.
  • Other duties as assigned or required.

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