Senior Test Engineer

The Senior Test Engineer (m/f/d) is a specialist in quality assurance and testing for AI-enabled computational pathology software and systems, ensuring quality, reliability, and regulatory readiness. As a testing expert when assigned, you will develop and execute comprehensive test strategies, influence testing approaches across disciplines via project teams, and act as an emerging expert in software testing for regulated medical applications.

With a track record of project delivery within your field of expertise, you will work with limited direction to define testing approaches, identify opportunities and synergies across projects, and contribute to validation objectives within computational pathology. You will demonstrate leadership through project teams, internal consulting, and mentoring junior test engineers while building external visibility through publications and presentations.

Your Responsibilities

• Test strategy and leadership: Own comprehensive strategies for AI-enabled computational pathology; define integration, system, regression, performance, and UAT approaches; proactively manage investigations; make decisions that achieve project objectives and improve effectiveness across projects.
• End-to-end execution and quality assurance: Oversee testing across pipelines, services, and user workflows; design suites that ensure quality, reliability, and regulatory compliance; provide reliable results for program decision-making.
• Regulatory and compliance leadership: Ensure practices meet GxP, GDPR, ISO 13485, IEC 62304, and SaMD; maintain audit-ready evidence; contribute to FDA/EMA/IVDR submissions; improve SOPs; ensure requirements-to-test-to-evidence traceability; prepare validation packages.
• Advanced test development and automation: Create sophisticated test cases, reproducible data/fixtures for complex image and AI workflows; build and maintain automated frameworks (API, UI, data pipeline, model serving); integrate automation into CI/CD with best practices; innovate methods and apply specialist test automation expertise.
• Data and AI model validation: Validate data pipelines and model workflows; assess performance, robustness, generalizability, reproducibility, stability, explainability, and subgroup outcomes; design edge-case and distribution-shift tests; evaluate fairness/bias with diverse test data.
• Defect management and problem solving: Identify, reproduce, document, and track defects with root-cause analysis; collaborate to triage and verify fixes; prevent regression via strategic, risk-based coverage; engage experts to resolve complex issues.
• Environment and infrastructure readiness: Design production-like test environments using containers, Kubernetes, and cloud; seed synthetic and realistic data; manage artifacts, versioning, and test data governance; independently resolve tooling and infrastructure challenges.
• Stakeholder influence, mentorship, and visibility: Communicate complex results to diverse audiences; build relationships across engineering, data science, product, clinical, and regulatory; lead collaborations; mentor juniors; share best practices; contribute publications and presentations; establish external recognition and author complex test reports.

• Master’s or Bachelor’s degree (MSc, MTech, BTech or equivalent) in Computer Science, Software Engineering, Life Sciences, or a related field, with proven software testing experience in a regulated medical device, IVD, or pharmaceutical environment (typically 5+ years with a Master’s, 7+ with a Bachelor’s).
• Experience contributing to regulatory submissions (FDA, EMA, IVDR) for AI-enabled diagnostics or SaMD is a must.
• Domain expertise in Software as a Medical Device (SaMD) validation and AI systems validation is a must.
• Active participation in professional organizations or standards bodies (ISTQB, ASQ, etc.)
• Track record of successful project delivery in software testing, with examples of achieving key project objectives
• Proven experience developing and executing comprehensive test strategies for complex software systems
• Specialist knowledge in software testing methodologies, test automation, and quality assurance
• Hands-on experience with a test management tool (e.g., Jira with Xray or Zephyr) for authoring, executing, and tracking test cases; plus pytest, CI/CD (GitHub Actions), and code quality tools (e.g., SonarQube)
• Strong experience with UI/API test frameworks (e.g., Playwright, Cypress, Postman, or similar)
• Proficiency in Python for test automation; TypeScript/JavaScript experience is beneficial
• Proven experience testing cloud-deployed solutions with AWS, Docker, and Kubernetes
• Experience testing data pipelines, model-serving endpoints, and AI/ML workflows
• Understanding of reproducibility, MLOps concepts, and AI model validation
• Familiarity with ISO 13485, IEC 62304, SaMD validation, and traceability practices
• Demonstrated ability to mentor and develop junior professionals
• Excellent problem-solving, analytical, and critical thinking skills
• Strong written and verbal communication skills, with ability to explain complex concepts to diverse audiences
• Collaborative mindset with proven ability to influence across disciplines

What Will Set You Apart

• Active participation in professional organizations or standards bodies (ISTQB, ASQ, etc.)
• ISTQB Advanced or Expert level certification, or equivalent
• Knowledge of digital pathology formats, workflows, and image analysis
• Experience with performance testing, security testing, and accessibility testing
• Familiarity with risk-based testing approaches and FMEA
• Experience acting as key contact for external collaborations or vendor relationships
• Track record of process improvement and quality initiative leadership

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

Site Description - Munich, Germany

Welcome to Computational Pathology Munich, one of over 400 sites here at AstraZeneca, providing a collaborative environment where everyone can feel comfortable to be themselves-a value that is at the core of AstraZeneca’s priorities. To help you maintain your best self, here’s a sneak peek into some of the things we provide: after-work events, lunch & learns, a spacious and sustainable office working environment, events, family and childcare support and of course the Alps around the corner for hiking, biking and skiing. \n