Senior Medical Device Development Specialist

2 days ago

Dublin, Dublin City, Ireland beBeeDevelopment Full time €100,000 - €140,000

Senior Medical Device Development Specialist

We are seeking a highly skilled professional to lead the design, development, and performance evaluation of drug-device combination products in our team in Dublin.

About the Role:

  • The successful candidate will provide subject matter expertise to support formulation and manufacturing development activities for Combination Products.
  • The candidate will plan and execute design verification and reliability strategies, ensuring compatibility with device development.
  • This role will serve as the technical interface between drug product and device teams during combination product development.
  • The specialist will develop test methods and specifications to assess device functionality and product performance.
  • The candidate is responsible for material assessment of device components, including biological evaluation and extractables profiling.
  • This position provides technical support to manufacturing sites during filling and assembly process development.
  • The specialist will use statistical techniques to inform design decision making and conclusions.
  • The individual ensures that all activities within the team are conducted to appropriate quality standards.

Requirements:

  • A degree in Science or Engineering (Master's preferred).
  • At least 7 years' experience in pharmaceutical and/or medical device development.
  • A working knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485.
  • Experience in analytical method development and validation.
  • Applying statistical techniques for data analysis.
  • Writing and supporting regulatory submissions.
  • Excellent communication skills to lead or facilitate discussions.

About Us:

We deliver high-quality talent solutions to clients in the life sciences industry. We pride ourselves on excellence in everything we do.

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