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