FDA-Regulated Medical Device Test Architect

New York Technology Partners; Andover (MA); On-site; USD 150,000 - 190,000; Full time

Job summary

New York Technology Partners in Andover, MA is seeking an experienced Test Architecture Lead to design and implement backend test automation for FDA-regulated medical device software. You will shape end-to-end testing strategy, develop SVPs, and align with cybersecurity requirements.

You will integrate testing with CI/CD pipelines, mentor engineers, and drive measurable quality improvements through risk-based testing, tool evaluation, and audit-ready documentation.

Qualifications

• 9-13 years of total professional experience with at least 3 years of relevant experience in test architecture.
• Proven experience architecting end-to-end test automation frameworks in a medical device context.
• Experience working in FDA regulated medical device programs with demonstrated understanding of 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 for backend systems.
• Develop Software Verification Plans complying with FDA regulations.
• Create test strategies for functional, performance, security, and compliance requirements.
• Design test architectures integrating with CI/CD pipelines.
• Implement automated testing for APIs, microservices, and databases.
• Collaborate with cybersecurity and end-to-end architects on testing.
• Develop FDA-regulatory test documentation and audit readiness.
• Establish metrics to track test coverage and quality trends.
• Mentor test engineers and promote QA best practices.
• Evaluate tools and enable DevSecOps security testing.

Skills

Backend testing

Test architecture

FDA regulations

CI/CD integration

APIs testing

Cybersecurity testing

Mentoring

Documentation

Job description

New York Technology Partners in Andover, MA is seeking an experienced Test Architecture Lead to design and implement backend test automation for FDA-regulated medical device software. You will shape end-to-end testing strategy, develop SVPs, and align with cybersecurity requirements.

You will integrate testing with CI/CD pipelines, mentor engineers, and drive measurable quality improvements through risk-based testing, tool evaluation, and audit-ready documentation.