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

GlobalLogic Inc.; Waltham (MA); On-site; USD 130,000 - 140,000; Full time

Benefits offered by this job

Flexible work schedules

Work from home

Health and life insurance

401K and retirement benefits

PTO and holidays

Job summary

GlobalLogic Inc. in Waltham, MA is seeking a Principal Embedded Verification and Validation Engineer for medical devices. You will lead software quality assurance for embedded systems in a highly regulated environment, coordinating cross-functional teams.

The role demands 10–15 years of experience, hands-on testing of embedded software, and regulatory familiarity with FDA 510(k) and ISO 13485. Expect collaborative leadership, process improvements, and opportunities to shape validation strategies

Qualifications

• 10+ years of commercial software test engineering experience in medical devices or scientific instruments.
• 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.
• Deep familiarity with feature, regression, and integration testing for complex systems.
• Experience with ALM tools for backlog, sprint boards, and test case management.

Responsibilities

• Embedded V&V leadership: lead development, review, and execution of software QA processes for embedded medical devices.
• Hardware/software integration testing: execute manual and automated tests verifying software controlling hardware.
• Regulatory validation: oversee software validation activities per FDA and ISO 13485.
• Iterative process improvement: implement tool/process improvements with Agile cycles.
• Documentation & approvals: write/review validation plans, protocols, summary reports, cyber risk mitigations.
• Cross-functional mentorship: participate in ceremonies, estimate, mentor junior staff.

Skills

Embedded

Embedded Software Testing

FDA 510(k)

Healthcare-Medical Devices

Tools

Azure DevOps

Job description

GlobalLogic Inc. in Waltham, MA is seeking a Principal Embedded Verification and Validation Engineer for medical devices. You will lead software quality assurance for embedded systems in a highly regulated environment, coordinating cross-functional teams.

The role demands 10–15 years of experience, hands-on testing of embedded software, and regulatory familiarity with FDA 510(k) and ISO 13485. Expect collaborative leadership, process improvements, and opportunities to shape validation strategies