Senior Test Engineer (mfd) for regulated Computational Pathology products

About AstraZeneca

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 worlds most serious diseases. But were more than one of the worlds 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 themselvesa value that is at the core of AstraZenecas priorities. To help you maintain your best self heres 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.

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 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.

Your Profile

• Masters or Bachelors 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 Masters 7 with a Bachelors).

• 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

What You Can Expect:

• 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

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.