Senior Product Assurance Engineer for Combination Products

2 days ago

Dublin, Dublin City, Ireland beBeeDeviceDevelopment Full time €122,127 - €132,619
Job Description

The Principal Device Development Assurance Scientist/Engineer will play a pivotal role in ensuring the design and development of combination products comply with design control requirements outlined in Quality Management Systems and relevant regulations.

This position will be responsible for supporting device development programs through the lifecycle of Combination products, including prefilled pens, prefilled syringes, autoinjectors, and medical devices.

Key Responsibilities:

  • Develop and maintain Design History Files for development programs.
  • Collaborate with affiliate sites, collaborators, and third parties to establish and maintain objective evidence and controls.
  • Support the integration and assess compliance with design control requirements of acquired combination products and medical devices into the Global Device Development product portfolio.
  • Support Risk Management activities for development programs through the implementation of ISO 14971:2019.
Required Skills and Qualifications

To succeed in this role, you will require a strong background in engineering or science/life science, industry experience in Medical Device or Pharmaceutical (with devices), and proven experience in device development and manufacturing operations activities for device or drug/device systems in a GMP environment.

Key qualifications include:

  • Education: Degree / Masters in engineering or science/life science.
  • Industry: Medical Device or Pharmaceutical (with devices).
  • Proven experience in similar level/general experience in industry.
  • Direct experience of device development and manufacturing operations activities for device or drug/device systems in a GMP environment.
About This Opportunity

Viatris is committed to building a diverse, inclusive, and authentic workplace where individuals can thrive. We encourage applications from candidates who are passionate about device development and manufacturing operations activities.

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