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Medical Device Development Lead

3 weeks ago

Dublin, Dublin City, Ireland beBeeDevelopment Full time €96,000 - €134,000
Senior Medical Device Development Professional

The successful candidate will lead the design, development, and performance evaluation of drug-device combination products.

  • Provide subject matter expertise to support the development of Combination Products
  • Plan and execute design verification and reliability strategies
  • Be the technical interface between drug product and device teams during combination product development
  • Responsible for the development of 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
  • Responsible for 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
  • Use statistical techniques or data analysis to inform design decision making and conclusions

For this role, we require a degree in Science/Engineering, 7+ years' experience in pharmaceutical and/or medical device development, and working knowledge of design control requirements. The ideal candidate should also possess experience in the development and validation of analytical methods, application of statistical techniques, and writing regulatory submissions.

Key Skills and Qualifications:
  • Strong understanding of Combination Product development principles
  • Ability to apply statistical techniques to inform design decisions
  • Excellent communication skills with ability to work across functions
  • Experience with regulatory submission preparation
Why Choose This Opportunity?

This is an exciting opportunity for a Senior Medical Device Development Professional to join our organization and contribute to the development of innovative Combination Products. We offer a collaborative and dynamic work environment with opportunities for professional growth and development.