Embedded Verification and Validation (V&V) Engineer

• Experience: 10+ years of commercial software test engineering experience, with a proven track record in a medical device or scientific instrument environment.

• Deep Embedded Expertise: Extensive, hands-on experience testing deeply embedded systems where software directly controls physical hardware components.

• Regulatory Mastery: Proven commercial experience testing and shipping medical devices under ISO 13485, along with familiarity with current FDA cybersecurity requirements.

• Testing Methodologies: Deep familiarity with feature, regression, and integration testing for complex systems.

• Tooling: Hands-on experience utilizing enterprise Application Lifecycle Management (ALM) systems (such as Azure DevOps) for backlog, sprint board, and test case management.

Job Responsibilities

Embedded V&V Leadership: Lead the development, review, and execution of software quality assurance processes specifically for embedded medical devices.

Hardware/Software Integration Testing: Execute manual and automated test cases to verify software that controls hardware as part of an overall scientific instrument system.

Regulatory Validation: Conduct and oversee software validation activities in strict accordance with FDA regulations and ISO 13485.

Iterative Process Improvement: Implement tool and process improvements to bring verification test case writing and approval concurrent with iterative Agile development cycles.

Documentation & Approvals: Review, author, and approve critical software documentation, including validation plans, protocols, summary reports, and cybersecurity risk mitigations.

Cross-Functional Mentorship: Actively participate in development team ceremonies, review work item acceptance criteria, provide input on estimations, and mentor junior testing staff.