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Medical Device Validation Specialist

3 weeks ago

Dublin, Dublin City, Ireland beBeeValidation Full time
Senior Validation Expert

The Senior Validation Expert plays a pivotal role in ensuring the quality and reliability of medical devices. This critical position involves executing design verification and validation testing to support product lifecycle management and new product development.

The ideal candidate will have expertise in developing and qualifying test systems and methods, as well as experience with executing Design Verification and/or Design Validation on mechanical or electromechanical medical devices.

A degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Systems Engineering, or a related field is required, along with 8+ years of professional experience in the medical device, pharmaceutical, or life sciences field.

This role requires strong analytical skills, with proficiency in statistical data analysis methods using tools like Minitab or SAS. The successful candidate will also have working knowledge of applicable medical device regulatory standards.

The Senior Validation Expert will work closely with cross-functional teams, including Operations, Quality, and IT/Infrastructure groups, to achieve design verification and validation deliverables.

  • Develops new or optimizes existing physical test methods and test fixtures to support design verification, validation, and commercialization of new medical device products and changes to existing products.
  • Drafts engineering technical reports, test method work instructions, or procedures, and test method validation-related documents.
  • Leads/executes test method validation (TMV), design verification, and test method transfer, in support of product design verification or validation.
  • Authors design verification protocols to satisfy product design inputs/system requirements that satisfy applicable Quality System (QS) and regulatory requirements.
  • Manages and tracks product configurations through design verification and validation.
  • Performs hands-on and simulated testing for design verification and test method developments.
  • Conducts functional and performance testing of products to ensure that the product and its components meet the required specifications.