Test Architect - Medical Device Backend | FDA Compliance

Capgemini; Andover (MA); On-site; USD 54,000 - 85,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Retirement benefits

Job summary

Capgemini in the Greater Boston region is seeking a seasoned Test Architect to design and implement comprehensive test strategies for backend systems of a medical device platform. You will ensure FDA regulatory compliance, validate functionality, performance, and security, and integrate testing with CI/CD pipelines.

You will lead end-to-end test automation, mentor engineers, and collaborate with cybersecurity and DevSecOps teams to strengthen quality across the software lifecycle in a regulated

Qualifications

• 9-13 years of total professional experience with at least 3 years of relevant experience in test architecture.
• Experience architecting end-to-end test automation frameworks in a medical device context.
• Experience with FDA regulated medical device programs and cybersecurity practices.
• Extensive experience developing Software Verification Plans and test strategies that meet regulatory requirements.
• Experience with test automation tools and frameworks for backend systems.
• Knowledge of risk-based testing approaches and their application in regulated environments.
• Understanding of FDA documentation requirements for software verification and validation.
• Strong analytical and problem-solving skills with attention to detail and quality.
• Excellent communication skills with the ability to explain complex testing concepts to various stakeholders.
• Experience mentoring test engineers and promoting quality best practices.
• Knowledge of medical device software development lifecycle and regulatory requirements.
• Ability to balance thorough testing with efficient delivery timelines.
• Strong knowledge of CI/CD frameworks and integration of automated testing into continuous delivery pipelines.
• Deep understanding of backend testing methodologies for APIs, microservices, and databases.
• Experience with performance testing and security testing of backend systems.

Responsibilities

• Architect end-to-end test automation frameworks and strategies for backend systems.
• Develop Software Verification Plans that comply with FDA regulations.
• Create test strategies addressing functional, performance, security, and compliance.
• Design test architectures that integrate with CI/CD pipelines.
• Implement automated testing solutions for APIs, microservices, and databases.
• Collaborate with the End-to-End Architect and Cybersecurity Architect to ensure comprehensive testing.
• Develop test documentation meeting FDA requirements and audit readiness.
• Establish metrics to track test coverage and quality trends.
• Mentor test engineers and promote QA best practices.
• Evaluate and recommend testing tools and technologies.
• Work with DevSecOps to integrate security testing.
• Participate in design reviews to ensure testability.
• Create risk-based testing approaches prioritizing critical functionality.

Skills

Test architecture

Automation frameworks

FDA regulations

Cybersecurity practices

Software verification plans

CI/CD integration

API testing

Performance testing

Security testing

Mentoring

Backend testing

Tools

Test automation tools

Backend testing tools

Job description

Capgemini in the Greater Boston region is seeking a seasoned Test Architect to design and implement comprehensive test strategies for backend systems of a medical device platform. You will ensure FDA regulatory compliance, validate functionality, performance, and security, and integrate testing with CI/CD pipelines.

You will lead end-to-end test automation, mentor engineers, and collaborate with cybersecurity and DevSecOps teams to strengthen quality across the software lifecycle in a regulated