Senior Device and Product Performance Specialist

4 days ago

Dublin, Dublin City, Ireland beBeeDevicePerformance Full time €113,443 - €151,324
Device and Product Performance Expert

The role of the Device and Product Performance Expert involves being a key member of our Global Device Development team, providing subject matter expertise to support the development of Combination Products. This includes leading a team to plan and execute design verification and reliability strategies, ensuring technical interface between drug product and device teams during combination product development, and developing test methods and specifications to assess device functionality and product performance.

Key Responsibilities:

  • Lead a team in planning and executing design verification and reliability strategies
  • Provide technical interface between drug product and device teams during combination product development
  • Develop design requirements and specifications based on characterization of comparator products, regulatory requirements, design intent, and user requirements
  • Develop test methods and specifications to assess device functionality and product performance
  • Use statistical techniques or data analysis to inform design decision making and conclusions
  • Ensure all activities within the team are conducted and executed to the appropriate quality standards within the GDD Quality Management system
  • Lead support activities for external and internal audits and inspections as applicable

Requirements:

  • Masters degree in Science/Engineering
  • Proven experience in pharmaceutical and/or medical device development
  • Working knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485
  • Experience in the development and validation of analytical methods
  • Experienced in application of statistical techniques for data analysis
  • Experience of writing and supporting regulatory submissions
  • Highly driven and motivated individual who can work as part of a flexible, dynamic team
  • Well-developed communication skills to lead or facilitate effective discussions

What We Offer:

  • A competitive compensation package
  • Ongoing professional development opportunities
  • A collaborative and dynamic work environment

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