Job Summary
We are seeking a skilled Validation & Verification Specialist to join our team. In this role, you will be responsible for the execution of design verification and design validation testing in support of product lifecycle management and new product development.
Key Responsibilities:
* Develop and optimize physical test methods and test fixtures to support the design verification, validation, and commercialization of new medical device products and changes to existing products.
* Create engineering technical reports, test method work instructions or procedures, and test method validation related documents.
* Lead/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.
* Manage and track product configurations through design verification and validation.
* Perform hands-on and simulated testing for design verification and test method developments.
* Conduct functional and performance testing of products to ensure that the product and its components meet the required specifications.
* Identify and report out-of-specification results, data, and atypical/unexpected events that occur during testing activities and support associated investigations, impact assessments, and Root Cause Analysis (RCA).