A Device and Product Performance Expert Role

9 hours ago

Dublin, Dublin City, Ireland beBeeProduct Full time €87,000 - €94,500
Job Title: Device and Product Performance Expert

At our organization, we are committed to empowering people worldwide to live healthier at every stage of life. We leverage our best-in-class manufacturing and scientific expertise to bring quality medicines to patients when and where they need them.

Job Description:

We are seeking a highly skilled Device and Product Performance Expert to join our innovative team. This is a unique opportunity to make a significant impact in the development of Combination Products.

The ideal candidate will have a degree in Science or Engineering and proven experience in pharmaceutical and/or medical device development. They will be responsible for providing technical expertise to support the development of Combination Products, including metrology testing, engineering verification, design verification, device functional stability, biological evaluation, method development, transport & shipping studies.

Key responsibilities include performing Development and Validation of Test Methods, dealing with external parties to support exhibit and registration batches, and overseeing the execution of testing at external test facilities. The successful candidate will also be responsible for trending and statistical analysis of analytical data, ensuring that Combination Products meet regulatory requirements, and compiling and reviewing technical documentation.

Required Skills and Qualifications:
  • Proven experience in pharmaceutical and/or medical device development
  • Experience in the development and validation of analytical methods
  • Application of statistical techniques for data analysis
  • Working knowledge of design control requirements
  • Experience of writing and supporting regulatory submissions
Benefits:

Our organization offers competitive salaries, benefits, and an inclusive environment where you can use your experiences, perspectives, and skills to make an impact on the lives of others.

Others:

Some travel will be required as part of this role. You will be working as part of a flexible, dynamic team and taking responsibility for individual tasks.

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