Product Performance Expert

1 week ago

Dublin, Dublin City, Ireland beBeeDevelopment Full time €50,000 - €70,000
Scientist, Device and Product Performance

Job Overview:

The Device Development Scientist plays a crucial role in the development of Combination Products. They are responsible for providing technical expertise to support the design verification testing of devices.

The ideal candidate will have a strong background in Science/Engineering, with proven experience in pharmaceutical and/or medical device development.

Key responsibilities include performing development and validation of test methods, generating protocols, overseeing execution of testing at external test facilities, and writing reports.

The Device Development Scientist must ensure that the Combination Product meets any requirements for reliability, through implementation of appropriate controls and assessment of the product against suitable specifications.

Additionally, they will be responsible for compilation and review of technical documentation within the Global Device Development portfolio, in line with global regulatory requirements and industry thinking.

Strong communication skills and the ability to lead or facilitate effective discussions are essential for this role.

Requirements:

  • Degree in Science/Engineering (Master's preferred)
  • Proven experience in pharmaceutical and/or medical device development
  • Experience in the development and validation of analytical methods
  • Experienced in application of statistical techniques for data analysis
  • Working knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485 would be an advantage
  • Experience of writing and supporting regulatory submissions would be an advantage
  • Highly driven and motivated person who can work as part of a flexible, dynamic team whilst taking responsibility for individual tasks
  • Well-developed communication skills to lead or facilitate effective discussions
  • Able to communicate technical and/or project information to key stakeholders

Location: Dublin, Ireland

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