Systems Validation Engineer

Job Description

The Systems Validation Engineer will be a technical expert responsible for leading Systems Engineering activities related to Verification and Validation of medical device products. Develop, review, implement and maintain test strategies, test protocols, test cases, test reports and traceability matrices for system verification while hardware and software components are verified for release. This person will report defects and any issues found to upper management and engineering teams working closely with System Automation Test team to optimize test coverage and test execution strategy.

Responsibilities:

Collaborate with Systems Engineering to ensure that requirements are testable and appropriately leveled for verification with component level test teams (Hardware/Software)

Provide technical leadership for System Design Verification team in preparation for product releases while leading initiatives to advance processes and tools related to Design Verification activities according to System Engineering COE department objectives

Coordinate with project managers, system engineers and other technical leads to plan and execute project goals and work closely with System Automation Test team to optimize test coverage and test execution strategy.

Manage and track product configurations including hardware, software, firmware version tracking and determine the impact due to configuration changes for System Design Verification.

Lead the development and execution of system integration, system verification and regression plan.

Develop, review, implement and maintain test strategies, test protocols, test cases, test reports and traceability matrices for system verification.

Deliver Verification and Validation activities for New Product Development and sustaining products.

Report defects found during testing and assist in root cause analysis.

Drive the impact analysis and effort estimates.

Define, track and report KPIs for product verification and product quality.

Mentor to junior team members on topics such as sample size justification, statistical analysis, risk-based test coverage optimization.

Ensure compliance with regulatory standards and quality policies, procedures and practices.

Required Skills/Experience:

Bachelor’s degree is required

Excellent verbal and written communications in English (written, verbal)

Minimum of 5 years’ experience software testing, System Testing and/Product testing in a multidisciplinary project team environment

2+ years of software testing, System Testing and/Product testing experience

Familiarity with medical device System Level Testing

Experience working in an Agile based Software Development environment

Good written and verbal communication skills including cross functional communication experience

Preferred:

Experience working with requirements management tool (Helix, Jama, and/or Polarion), quality management system, test case management tool, defect management tool is preferred

Previous automated testing experience is a plus

Full-time