Senior Mechanical Design Engineer

1 week ago


Dublin, Dublin City, Ireland beBeeMechanical Full time €85,000 - €125,000

Design Verification and Reliability Strategist

Job Description:

  • Develop technical interfaces between drug product and device teams during combination product development.
  • Create design requirements and specifications based on characterization of comparator products, regulatory requirements, design intent and user requirements.
  • Design test methods and specifications to assess device functionality and product performance.
  • Material assessment of device components, including biological evaluation, extractables profiling and material certification.

Responsibilities Include:

  • Leading a team to plan and execute design verification and reliability strategies.
  • Working closely with cross-functional teams to ensure formulation and manufacturing development activities are compatible and align with device development.
  • Developing analytical methods and applying statistical techniques for data analysis.

Requirements:

  • Master's degree in Science or Engineering.
  • At least 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 is an advantage.


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