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Principal Scientist/Engineer

2 weeks ago


Dublin, Dublin City, Ireland beBeeDevelopment Full time €120,000 - €145,000
Drug-Device Combination Product Development Lead

This is a highly skilled role that will lead the design, development and performance evaluation of drug-device combination products ensuring they meet regulatory and quality standards.

Responsibilities
  • Provide subject matter expertise for combination product development, planning and executing design verification and reliability strategies.
  • Be the technical interface between drug product and device teams during combination product development, developing test methods and specifications for device functionality and product performance.
  • Conduct material assessment of device components including biological evaluation, extractables profiling, and material certification.
  • Provide technical support to manufacturing sites during filling and assembly process development, using statistical techniques for data analysis to inform design decision making.
  • Lead support activities for external and internal audits and inspections.
Requirements
  • Master's degree in Science/Engineering.
  • 7+ years' experience in pharmaceutical and/or medical device development.
  • Working knowledge of design control requirements and ISO 13485.
  • Experience in analytical method development and validation.
  • Statistical technique application for data analysis.
  • Regulatory submission writing and support experience.
  • Excellent communication skills and ability to travel.