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

Posted Yesterday
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Munich, Bayern, DEU
In-Office
Senior level
Biotech • Pharmaceutical • Manufacturing
The Role
Develop, maintain, and lead software platforms, tools, and infrastructure for regulated computational pathology products. Implement production-quality features, follow V-model regulated development practices, support risk assessments, establish engineering controls and documentation, collaborate cross-functionally, provide technical leadership, and mentor engineers to ensure compliant, traceable, and scalable AI-enabled medical software delivery.
Summary Generated by Built In

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 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.

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.

The Senior AI Software Engineer (m/f/d), Regulated Platforms and Tools for Computational Pathology is a senior technical role focused primarily on software development for platforms, tools, and engineering frameworks used to build regulated 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 of AI-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 the software and platform foundations that allow computational pathology AI capabilities to be developed and integrated into regulated computational pathology products in a controlled, scalable, and compliant manner.

The role is especially suited to someone who can bridge software engineering discipline and AI product understanding, and who can help embed quality by design, risk-based thinking, and structured lifecycle execution into day-to-day engineering practice.

Your responsibilities

  • Design, develop, and maintain software 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 the V-model, including definition and management of requirements, design inputs, implementation controls, and support for verification and validation.

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

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

  • Collaborate and influence across disciplines including 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 initiatives by identifying common needs, re-usable approaches, and synergies across projects to improve efficiency, consistency, and compliance in regulated software development.

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

Your Profile

  • 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. 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

04-Aug.-2026

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.

Skills Required

  • Master's degree in computer science, software engineering, biomedical engineering, or related field (bachelor's with strong experience acceptable)
  • Experience in Software as a Medical Device (SaMD) or regulated healthcare/medical device software development
  • Prior experience with standards IEC 62304, ISO 13485, and ISO 14971
  • Practical experience with regulated software development practices (V-model, requirements management, traceability, verification/validation)
  • Experience contributing to functional risk assessments and implementing risk control measures
  • Strong hands-on coding and problem-solving ability
  • Experience with AI-enabled software systems, model integration, and AI development lifecycle considerations
  • Experience producing and maintaining structured software lifecycle documentation (requirements, specifications, test documentation, change records)
  • Familiarity with standard engineering tools: git/GitHub, CI/CD, code review workflows, and work tracking tools such as JIRA
  • Familiarity with container and cloud platform technologies: Docker, Kubernetes, and at least one major cloud (AWS, Azure, or GCP)
  • Strong analytical, written, and verbal communication skills
  • Experience supporting verification and validation activities in AI-enabled regulated software development
  • Knowledge of digital pathology workflows, image formats, and computational pathology applications
  • Experience mentoring junior engineers or supervising technical work
  • Experience contributing to technical presentations, publications, or engineering knowledge-sharing
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The Company
90,000 Employees
Year Founded: 1999

What We Do

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company committed to excellence in the research, development, and commercialization of prescription medicines. With approximately 90,000 employees across 85 countries, the company aims to unlock the power of science to deliver innovative medicines that transform patient outcomes and improve healthcare for people, society, and the planet worldwide.

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