Principal Embedded V&V Engineer – Medical Devices (Remote)

GlobalLogic Inc.; EE. UU.; Presencial; USD 130.000 - 140.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Exciting Projects

Collaborative Environment

Work-Life Balance

Professional Development

Excellent Benefits

Descripción de la vacante

GlobalLogic is seeking a Principal Embedded Verification and Validation Engineer for medical devices in Waltham, MA. You will lead verification activities for embedded software, ensuring robust test coverage for hardware-controlled systems within a regulated environment.

The role requires extensive experience with embedded testing, ISO 13485, and FDA cybersecurity considerations, plus hands-on use of ALM tools like Azure DevOps. Hybrid work options may be discussed based on project needs.

Formación

• 10+ years of commercial software test engineering experience in a medical device or scientific instrument environment.
• Hands-on testing of deeply embedded systems where software controls hardware.
• Experience testing and shipping medical devices under ISO 13485 and familiarity with FDA cybersecurity requirements.

Responsabilidades

• Lead development, review, and execution of software quality assurance processes for embedded medical devices.
• Execute manual and automated test cases to verify software that controls hardware as part of a system.
• Conduct and oversee software validation per FDA regulations and ISO 13485.
• Implement tool and process improvements to align verification with iterative Agile cycles.
• Review, author, and approve validation plans, protocols, reports, and cybersecurity risk mitigations.
• Mentor junior testing staff and participate in cross-functional team ceremonies.

Conocimientos

Embedded

Embedded Software Testing

FDA 510(k)

Healthcare-Medical Devices

Herramientas

Azure DevOps

Descripción del empleo

GlobalLogic is seeking a Principal Embedded Verification and Validation Engineer for medical devices in Waltham, MA. You will lead verification activities for embedded software, ensuring robust test coverage for hardware-controlled systems within a regulated environment.

The role requires extensive experience with embedded testing, ISO 13485, and FDA cybersecurity considerations, plus hands-on use of ALM tools like Azure DevOps. Hybrid work options may be discussed based on project needs.