Verification and Validation Engineer
Verification & Validation Engineer
6+ Months, M-F 40 hours weekly
Must be US Citizen, Local candidates preferred
The Senior Verification and Validation Engineer is responsible for the preparation, execution and documentation of testing activities in support of new product introductions. Starting from a database of requirements that encompasses the Client's product platforms, the Senior Verification and Validation Engineer will develop test methods, fixtures and procedures to first characterize and subsequently formally verify product performance.
Testing will be conducted at all levels, from component to sub-assembly to full system, and includes verification of performance and validation of user requirements. The Senior Verification and Validation Engineer owns formal verification activities including: planning, de-risking, protocol development, test execution, data analysis and report generation.
• Review and develop system and sub-system requirements leveraging their indepth knowledge of the product
• Write detailed test procedures that evaluate product and systems against documented mechanical, electrical and software requirements • Develop test methods and fixtures for all development testing including verification while collaborating with development teams or outside resources
• Execute the verification and validation of product design including requirements analysis, traceability, and testability assessment
• Prepare and execute test method and fixture qualifications. Fixtures may be mechanical, electromechanical, pneumatic, with or without software controls
• Conduct statistical analysis of test results
• Support completion of traceability of requirements through verification and validation reports
• Maintain and control test execution records using good lab practices • Automate tests where applicable
• Escalate, when appropriate, cross-functional support issues on projects to the Project Manager or to functional leadership
• Actively evaluate projects for opportunities to improve performance
• Continuously monitor risk and mitigate as appropriate
• Bachelor of Science degree or equivalent in applicable engineering field; Mechanical, Electrical, BioMedical.
• Minimum of 4 years experience in conducting verification and validation of electro/mechanical systems in a regulated industry.
Medical device development experience along with a solid working knowledge of FDA Quality System Regulations and ISO 13485, and IEC 60601 is highly preferred
• Possess the ability to analyze requirements and develop a risk-based approach to testing
• Familiarity with measurement equipment, preferably including mass flow controllers and other pneumatic elements
• Familiarity with requirement management tools leading to generation of complete traceability matrices (i.e. Doors, Jama, Test Track, etc.) • Familiarity with main standards applicable to the development of medical devices (i.e. IEC 60601-1, ISO 10993, etc.)
• Knowledge of statistical techniques for experimental design and data analyses
• Strong design control and documentation skills • Good technical writing skills, including development of test methods, protocols, reports
• Proficient computer skills with applicable software packages (e.g. Microsoft Office, Microsoft Project, Microsoft Power Point, etc.) and test data analysis software packages (JMP, Minitab, ReliaSoft, and/or Python)
• Good communication skills • Able to learn new technologies • Able to work independently and in a team environment
• Experience with respiratory equipment is a plus
• Excellent problem-solving skills
Job Status: Contract/Temporary