Software Quality Assurance (SQA) Engineer – Medical Device & AWS Cloud ApplicationsPosition Summary
We are seeking an experienced Software Quality Assurance (QA) Engineer to support the verification and quality assurance of connected medical device products and cloud-based healthcare applications hosted on AWS. This role will ensure software quality, regulatory compliance, cybersecurity, interoperability, and data integrity across the complete ecosystem, including embedded software, mobile/web applications, APIs, cloud infrastructure, and backend services.
Key ResponsibilitiesMedical Device Software Quality Assurance
- Develop and execute Software Verification plans, protocols, and reports for medical device software.
- Review software requirements, architecture, design documents, and risk management files for completeness and testability.
- Create and maintain test cases for embedded software, desktop applications, web portals, and cloud services.
- Verify software functionality, reliability, usability, performance, and security requirements.
- Execute manual and automated testing throughout the software development lifecycle.
- Support design verification, system validation, and release readiness activities.
Connected Device & Cloud Application Testing
- Validate end-to-end workflows between medical devices, web applications, APIs, and AWS cloud services.
- Verify secure transmission, storage, and retrieval of data.
- Test cloud-hosted applications for functionality, availability, scalability, recoverability, and reliability.
- Validate interoperability between medical devices and cloud services.
- Perform integration testing across devices, network, cloud, and third-party systems.
Cybersecurity & Data Integrity Testing
- Perform testing of security controls and cybersecurity risk mitigations.
- Verify user authentication, authorization, encryption, and access controls.
- Verify protection of data at rest and in transit.
Test Automation & CI/CD
- Develop and maintain automated test frameworks and regression test suites.
- Integrate automated testing into CI/CD pipelines.
- Create performance, load, and API test automation.
- Generate traceability matrices linking:
- User needs
- System requirements
- Software requirements
- Risk controls
- Verification test cases
Required Qualifications
- Bachelor's degree in computer science, Software Engineering, Biomedical Engineering, Electrical Engineering, or related fields.
- Excellent written documentation and communication skills.
- Strong understanding of software development lifecycle and Agile methodologies.
- Experience testing cloud-connected medical devices or healthcare applications.
- Experience with AWS-hosted applications and distributed systems.
- Experience with API, integration, system, regression, and performance testing.
- Knowledge of software verification and validation practices under ISO 13485.
Technical Skills
Testing Tools: Jira, XRay
Automation: Playwright, Postman
Languages: Python, C#, Typescript
Cloud & AWS: AWS IoT Core, Lambda, API Gateway, Cognito, CloudWatch
- DevOps & CI/CD: GitHub, AWS Code pipeline, Circle CI