Lead Process Development Engineer

3 days ago

Galway, Galway, Ireland beBeeEngineer Full time €40,000 - €50,000

Develop Complex Projects for Acute Ischemic Stroke

Key Responsibilities:
  • Collaborate with Cross-Functional Teams to develop robust product design and ensure capable manufacturing processes.
  • Evaluate critical to quality requirements for components used to build complex acute ischemic stroke devices, translating these 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 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 lines 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.
Requirements:
  • Degree in Mechanical or Biomedical Engineering or equivalent.
  • At least 5-7 years of medical device development experience in a regulated environment.
  • Prior experience in medical device catheter process design and or manufacturing is highly desirable.
  • Understanding of product lifecycle and validation requirements for new product introduction.
  • Experienced in developing validation strategies for equipment or processes, including preparation of FMEAs protocols and reports.
  • Proficiency in structured problem-solving approaches (e.g. Six Sigma, DMAIC)
  • Project Management experience, developing project schedules and managing resources and execution.

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