Device Performance and Development Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBeeDevelopment Full time €800,000 - €1,000,000

Job Title: Device Performance and Development Specialist

Are you a skilled scientist or engineer with experience in medical device development? Do you have a passion for creating innovative solutions that improve patient care?

About the Role

We are seeking a talented Device Performance and Development Specialist to join our team. As a key member of our global device development organization, you will be responsible for ensuring the quality and performance of our medical devices.

  • Key Responsibilities:
  • Provide subject matter expertise to support the development of combination products
  • Lead a team to plan and execute design verification and reliability strategies
  • Responsible for technical interface between drug product and device teams during combination product development
  • Develop design requirements and specifications based on characterization of comparator products
  • Develop test methods and specifications to assess device functionality and product performance
  • Assess device components for biological evaluation, extractables profiling, and material certification
  • Provide technical support to manufacturing sites during filling and assembly process development
  • Use statistical techniques to inform design decision making and conclusions
Requirements

To be successful in this role, you will need:

  • A degree in science or engineering (master's preferred)
  • Proven experience in pharmaceutical and/or medical device development
  • Working knowledge of design control requirements
  • Experience in analytical method development and validation
  • Experience in application of statistical techniques for data analysis
  • Experience in writing and supporting regulatory submissions
Benefits

We offer a competitive salary, benefits package, and an inclusive environment where you can make a real impact on patient care.

In this role, you will have the opportunity to work with a talented team of scientists and engineers who share your passion for innovation and excellence.

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