Description:
The Verification and Validation Engineer is responsible for the execution of design verification and design validation testing in support of product lifecycle management and new product development.
Responsibilities
- Develops new or optimizes existing physical test methods and test fixtures to support the 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
- Identifies and reports out of specification results, data, and atypical/unexpected events that occur during testing activities and supports associated investigations, impact assessments and Root Cause Analysis (RCA)
Educational Requirements
- Minimum of Bachelor’s degree in Engineering
- 3+ years of professional experience in the medical device, pharmaceutical or life sciences field.