Job
- Level
- Senior
- Job Field
- Test/QA
- Employment Type
- Full Time
- Contract Type
- Permanent employment
- Location
- Munich
- Working Model
- Onsite
Job Summary
In this role, you will develop comprehensive test strategies and automate test cases for AI-enabled systems in computational pathology, ensuring quality standards and advising stakeholders.
Job Technologies
Your role in the team
- We are looking for an experienced Senior Test Engineer (m/f/d) for regulated Computational Pathology products to join our Computational Pathology team in Munich.
- 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 proven track record of project delivery within your area of expertise, you will work with minimal guidance to define testing strategies, 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.
- 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.
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Our expectations of you
Education
- 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).
Qualifications
- 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
- Specialist knowledge in software testing methodologies, test automation, and quality assurance
- Understanding of reproducibility, MLOps concepts, and AI model validation
- Vertrautheit mit ISO 13485, IEC 62304, SaMD-Validierung und Traceability-Praktiken
- Demonstrierte Fähigkeit, Junior Professionals zu betreuen und weiterzuentwickeln
- 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
Experience
- Experience contributing to regulatory submissions (FDA, EMA, IVDR) for AI-enabled diagnostics or SaMD is a must.
- Proven experience developing and executing comprehensive test strategies for complex software systems
- 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)
- Starke Erfahrung mit UI/API-Testframeworks (z. B. Playwright, Cypress, Postman oder ähnliches)
- 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
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What we offer
- Individual development opportunities with a focus on lifelong learning
- Trust, appreciation, and room to shape things in a focused and passionate team
- Modern office space in Munich enabling collaborative, flexible, and agile work
- A diverse, inclusive, and bias-free work environment, actively welcoming applications from all qualified candidates, regardless of background or characteristics
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Topics You Will Work On
Job Locations
About Your Employer
Astra Zeneca GmbH
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines.
Description
- Company Size
- 250+ Employees
- Company Type
- Established Company
- Working Model
- Hybrid, Onsite
- Industry
- Pharmaceutical Sector, Chemical Industry, Biotech
Senior Test Engineer
- Location
- Munich
- Working Model
- Onsite
- Diversity
- Open for all genders
- English Only
- English only required
