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Senior Engineering Lead

3 weeks ago

Co Meath, Ireland beBeeScientist Full time €90,000 - €120,000

About This Role

  • As a Principal Scientist in Mechanical Design, you will provide subject matter expertise to support the development of combination products.
  • You will be responsible for mechanical design and development of combination products, leading a team to plan and execute design verification and reliability strategies.
  • You will have technical interface between drug product and device teams during combination product development, ensuring formulation and manufacturing development activities are compatible and align with device development.
  • You will develop design requirements and specifications based on characterisation of comparator products, regulatory requirements, design intent and user requirements.
  • You will develop test methods and specifications to assess device functionality and product performance, implementing evaluation, procurement & new lab testing equipment as applicable.
  • You will conduct material assessment of device components, including biological evaluation, extractables profiling and material certification.

Key Skills Required

  • Mechanical design and development of combination products.
  • Design verification and reliability strategies.
  • Technical interface between drug product and device teams.
  • Design requirements and specifications.
  • Test methods and specifications.
  • Material assessment of device components.

What We Are Looking For In A Candidate

  • Degree in Science/Engineering (Master's preferred).
  • 7+ years' 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 would be an advantage.
  • Experience in the development and validation of analytical methods.
  • Experienced in the application of statistical techniques for data analysis.
  • Experience of writing and supporting regulatory submissions.

About Our Company

We are a dynamic and innovative organisation committed to delivering cutting-edge solutions in the field of combination product development. Our team of experts is dedicated to providing high-quality services that meet the evolving needs of our clients.