Principal Embedded V&V Engineer (Medical Device)

Hi Associate,

Greetings for the day,

We have a position as a Principal Embedded V&V Engineer (Medical Device) role in Waltham, MA. Please find the job description below for this position.

Role: Principal Embedded V&V Engineer (Medical Device)

Location: Waltham, MA

Duration: 24 Months

Job Description:

• 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.

Nice to Have:

• Previous experience acting as a V&V Manager or Test Lead.
• Bachelor's degree or higher in computer science, engineering, or a related technical discipline.
• Background in developing automated test scripts for hardware-in-the-loop (HIL) environments.

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.

Thanks & Regards

RAJU REDDY |Sr. Team Manager

CIS Technology Inc

Plano, TX 75074

Direct: