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.