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Principal Scientist Design

Principal Scientist Design

hays-gcj-v4-pd-onlineMeath
30+ days ago
Job description

Here, in Hays Recruitment, our Pharmaceutical client in Dublin is hiring a Principal Scientist Mechanical Design for combination products.

Your new role

  • Provision of subject matter expertise to support the development of Combination Products
  • Responsible for mechanical design and development of combination products.
  • Leading a team to plan and execute design verification and reliability strategies.
  • Responsible for the 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.
  • Responsible for the development of design requirements and specifications based on characterisation of comparator products, regulatory requirements, design intent and user requirements.
  • Responsible for developing test methods and specifications to assess device functionality and product performance, implementing evaluation, procurement & implementing new, state-of-the-art lab testing equipment as applicable.
  • Responsible for material assessment of device components, including biological evaluation, extractables profiling and material certification.

What you'll need to succeed

  • 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
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    Principal Scientist • Meath