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Senior Validation Engineer

2 weeks ago

Dún Laoghaire, Dún Laoghaire-Rathdown, Ireland beBeeValidation Full time €60,000 - €100,000

Delivering Quality and Safety in Medical Devices

About the Role
  • We are seeking a skilled Validation Engineer to join our team. As a Validation Engineer, you will play a critical role in ensuring the quality and safety of our medical devices.
  • You will be responsible for developing and optimizing physical test methods and test fixtures to support design verification, validation, and commercialization of new medical device products.
  • Your expertise in drafting engineering technical reports, test method work instructions or procedures, and test method validation-related documents will be invaluable to our team.
  • You will lead/executes test method validation (TMV), design verification, and test method transfer in support of product design verification or validation.
  • You will author design verification protocols to satisfy product design inputs/system requirements that meet applicable Quality System (QS) and regulatory requirements.
  • You will manage and track product configurations through design verification and validation.
  • You will perform hands-on and simulated testing for design verification and test method developments.
  • You will conduct functional and performance testing of products to ensure they meet required specifications.
Requirements
  • Bachelor's degree in Engineering.
  • 3+ years of professional experience in the medical device, pharmaceutical, or life sciences field.
Key Skills
  • Experience in developing and qualifying test systems and methods in support of product development and launch.
  • Experience executing Design Verification.
  • Experience in statistical data analysis methods/tools, e.g., Gage R&R, Hypothesis Testing.

We offer a diverse and inclusive work environment where everyone is valued and respected. We are committed to equal employment opportunity and do not discriminate based on race, color, religion, age, sex, national origin, disability, or any other protected characteristic.