Test Architect

Possible 3 Month CTH
Role name: Test Architect
Work Location: Andover, Massachusetts (Hybrid)
Start date: Immediate availability.
Background check MANDATORY

Role is Hybrid, can be initially remote
As a Test Architect for our medical device manufacturer client in the Greater Boston region, you will be responsible for designing and implementing comprehensive test strategies and frameworks for the backend systems of a platform that monitors and controls geographically dispersed medical device assets. You will ensure that all testing activities meet FDA regulatory requirements while validating system functionality, performance, and security.
Key Responsibilities:
Architecting end-to-end test automation frameworks and strategies for backend systems in a medical device context
Developing comprehensive Software Verification Plans that comply with FDA regulations and quality standards
Creating test strategies that address functional, performance, security, and compliance requirements for medical device software
Designing test architectures that integrate seamlessly with CI/CD pipelines for continuous testing and validation
Implementing automated testing solutions for APIs, microservices, and database components
Collaborating with the End-to-End Architect and Cybersecurity Architect to ensure testing covers all critical aspects of the system
Developing test documentation that meets FDA regulatory requirements and supports audit readiness
Establishing metrics and reporting mechanisms to track test coverage, effectiveness, and quality trends
Mentoring test engineers and promoting best practices in test automation and quality assurance
Evaluating and recommending testing tools and technologies that enhance testing efficiency and effectiveness
Working with the DevSecOps team to integrate security testing into the overall test strategy
Participating in design reviews to ensure testability of backend components
Creating risk-based testing approaches that prioritize critical functionality and potential failure modes
Mandatory Skills:
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