Senior Verification and Validation Engineer
We are working with a growing therapeutics company in Waltham,MA looking to add a Sr. V & V Engineer to the team! You will be responsible for the preparation, execution and documentation of testing activities in support of new product introductions.
The Senior Verification and Validation Engineer will be responsible for:
- Must be able to prepare and execute test method and fixture qualifications. Fixtures may be mechanical, electromechanical, pneumatic
- Write test procedures that evaluate product and systems against documented mechanical, electrical and software requirements
- Will execute the verification and validation of product design including requirements analysis, traceability, and testability assessment
- Conduct statistical analysis of test results
The Senior Verification and Validation Engineer should have the following qualifications:
- 4 years of experience in conducting verification and validation of electro/mechanical systems in a regulated industry.
- Medical device development experience and knowledge of FDA Quality System Regulations
- ISO 13485, and IEC 60601 is highly preferred
- Experience/Knowledge with measurement equipment, including mass flow controllers and other pneumatic element
- Familiar with requirement management tools leading to generation of complete traceability matrices (i.e. Doors, Jama, Test Track, etc.)
We are actively interviewing so don't hesitate to Apply Now!
