Senior AI Software 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 AI Software Engineer (m/f/d) for regulated Computational Pathology products

to join our Computational Pathology team in Munich.

TheSenior AI Software Engineer (m/f/d) Regulated Platforms and ToolsforComputational Pathologyis a senior technical role focused primarily onsoftware developmentfor platforms tools and engineering frameworks used to buildregulated medical computational pathology products. While the role sits within the AI engineering space its core emphasis is on building robust software systems and development infrastructure that enable the safe traceable scalable and compliant development ofAI-enabled medical software.

This role has a primary focus on software development not pure model research or algorithm development role. Success in the role depends on building thesoftware and platform foundationsthat allow computational pathology AI capabilities to be developed and integrated intoregulated computational pathology productsin a controlled scalable and compliant manner.

The role is especially suited to someone who can bridgesoftware engineering disciplineandAI product understanding and who can help embedquality by designrisk-based thinking andstructured lifecycle executioninto day-to-day engineering practice.

Your responsibilities

• Design develop and maintainsoftware platforms internal tools and enabling infrastructure for regulated computational pathology products ensuring solutions are scalable maintainable and suitable for controlled development and deployment environments.

• Hands-on programming and feature implementation: Designs codes tests debugs and maintains production-quality software features for regulated AI and computational pathology platforms translating requirements into robust implementations with appropriate documentation traceability and compliance with established development controls.

• Follow regulated software development practices for AI-enabled products using theV-model including definition and management of requirements design inputs implementation controls and support for verification and validation.

• Support functional risk assessment activitiesfor AI-enabled software features workflows and platform components including identification of risks definition ofmitigations and linkage of risk controls to design and verification evidence.

• Establish and improve regulated engineering processesacross projects including documentation standards configuration management change control code review practices release governance and defect management.

• Collaborate and influence across disciplinesincluding software engineering data science pathology product quality and regulatory teams to resolve complex issues align technical solutions to product needs and support delivery of project objectives.

• Provide technical leadership across multiple initiativesby identifying common needs re-usable approaches and synergies across projects to improve efficiency consistency and compliance in regulated software development.

• Mentor and guide other engineersin regulated software engineering practices serving as an internal expert in design controls risk-based development and structured software lifecycle execution.

Your Profile

• Masters degree in computer science software engineering biomedical engineering or a related field. A bachelors degree with strong relevant industry experience is also acceptable. Candidates with alternative backgrounds (biology physics engineering or mathematics) with equivalent practical experience considered.

• Experience in Software as a Medical Device (SaMD) regulated healthcare software or medical device software development is a must.

• Prior and proven experience of working with standards and frameworks such as IEC 62304 ISO 13485 and ISO 14971 is a must.

• Strong hands-on coding and problem-solving ability are essential; candidates may have developed their software engineering skills through domain-driven work.

• Experience working with AI-enabled software systems with sufficient understanding of AI development workflows model integration and lifecycle considerations while maintaining a primary identity as a software engineer.

• Practical experience with regulated software development or similarly controlled software environments including knowledge of 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 control measures.

• Experience producing and maintaining structured software lifecycle documentation such as 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 work tracking tools such as JIRA.

• Familiarity with cloud and platform technologies including Docker Kubernetes and at least one major cloud environment such as AWS Azure or GCP.

• Strong analytical problem-solving written and verbal communication skills.

What Will Set You Apart

• Experience supporting verification and validation activities in AI-enabled regulated software development.

• Familiarity with AI-enabled software systems and their development considerations in regulated contexts.

• Knowledge of digital pathology workflows image formats and computational pathology applications.

• Experience mentoring junior engineers or supervising technical work.

• Experience contributing to internal or external technical presentations publications or engineering knowledge-sharing activities.

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.