Senior AI Software Engineer (m/f/d) for regulated Computational Pathology products
AstraZeneca2 hours ago
Munich, GermanySenior
Responsibilities
- Design, develop, and maintain scalable software platforms, internal tools, and enabling infrastructure for regulated computational pathology products.
- Implement, test, debug, document, and maintain production-quality software features for regulated AI and computational pathology platforms.
- Apply V-model regulated software development practices, including requirements management, design inputs, implementation controls, verification, and validation support.
- Support functional risk assessments by identifying risks, defining mitigations, and linking risk controls to design and verification evidence.
- Establish and improve documentation, configuration management, change control, code review, release governance, and defect management processes.
- Collaborate with software engineering, data science, pathology, product, quality, and regulatory teams.
- Provide technical leadership by identifying reusable approaches and synergies across projects.
- Mentor and guide engineers in regulated software engineering, design controls, risk-based development, and structured software lifecycle execution.
Requirements
- Master’s degree in computer science, software engineering, biomedical engineering, or a related field; a bachelor’s degree with strong relevant industry experience is also acceptable.
- Equivalent practical experience from alternative backgrounds such as biology, physics, engineering, or mathematics may be considered.
- Proven experience with Software as a Medical Device, regulated healthcare software, or medical device software development.
- Proven experience with IEC 62304, ISO 13485, and ISO 14971.
- Strong hands-on coding, analytical, problem-solving, written, and verbal communication skills.
- Experience with AI-enabled software systems, AI development workflows, model integration, and lifecycle considerations.
- Experience with regulated or similarly controlled software development, including the V-model, requirements management, risk-based development, traceability, and verification practices.
- Experience contributing to functional risk assessments, documenting software risks, and implementing or supporting risk controls.
- Experience producing and maintaining requirements, specifications, design documentation, test documentation, and change records.
- Experience with standard software engineering practices and tools, including Git, GitHub, CI/CD, code review, and JIRA.
- Familiarity with Docker, Kubernetes, and at least one major cloud environment such as AWS, Azure, or GCP.
- Preferred qualifications include experience supporting verification and validation of AI-enabled regulated software, knowledge of digital pathology workflows and image formats, mentoring experience, and technical presentations, publications, or knowledge-sharing contributions.
Benefits
- Individual development opportunities focused on lifelong learning.
- Modern Munich office supporting collaborative, flexible, and agile work.
- Diverse, inclusive, and bias-free work environment.
- After-work events, lunch and learns, family and childcare support, and access to outdoor activities near the Alps.
- Location: Munich, Germany; posted 04-Aug.-2026.
About AstraZeneca
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