Principal Embedded Verification and Validation (V&V) Engineer_Medical Device IRC305263

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

Principal Embedded Verification and Validation (V&V) Engineer_Medical Device IRC305263

Function

IT, Telecom & Internet

Experience

10-15 years

Location

United States - Waltham MA

Skills

Embedded, Embedded Software Testing, FDA 510(k), Healthcare-Medical Devices

GlobalLogic estimates the starting base salary for thePrincipal Embedded Verification and Validation (V&V) Engineer position in Waltham, MA to be between $130000 to $140000 and reflects base salary only and does not include additional performance-linked variable compensation, benefits etc that may be applicable for the role. This pay range is provided as a good faith estimate and the amount offered may be higher or lower. GlobalLogic takes many factors into consideration in making an offer, including candidate qualifications, work experience, operational needs, travel and onsite requirements, internal peer equity, prevailing wage, responsibilities, and other market and business considerations.

Requirements

• 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.

What we offer

Exciting Projects:Come take your place at the forefront of digital transformation! With clients across all industries and sectors, we offer an opportunity to work on market-defining products using the latest technologies.

Collaborative Environment: You can expand your skills by collaborating with a diverse team of highly talented people in an open, laidback environment — or even abroad in one of our global centers or client facilities!

Work-Life Balance:GlobalLogic prioritizes work-life balance, which is why we offer flexible work schedules and opportunities to work from home.

Professional Development:We provide continuing education classes, professional certification and training (technical, soft skills, language, and communication skills) to help you realize your professional goals. Being part of a global organization, there are additional learning opportunities through international knowledge exchanges.

Excellent Benefits:We provide our employees with competitive salaries, health and life insurance, short-term and long-term disability insurance, a matched contribution 401K plan, flexible spending accounts, and PTO and holidays

About GlobalLogic

GlobalLogic, a Hitachi Group Company, is a trusted digital engineering partner to the world’s largest and most forward-thinking companies. Since 2000, we’ve been at the forefront of the digital revolution – helping create some of the most innovative and widely used digital products and experiences. Today we continue to collaborate with clients in transforming businesses and redefining industries through intelligent products, platforms, and services.