Release Engineer / Technical Lead, Software & Electronics

Ambu A/S; Augsburg; Vor Ort; EUR 60.000 - 85.000; Vollzeit

Zusammenfassung

Ambu A/S in Augsburg is seeking a Release Engineer / Technical Lead to manage AI-powered software features for endoscopy systems. The ideal candidate has a degree in Computer Engineering or a related field, strong experience with medical device regulations, and excellent collaboration skills. This role involves driving compliance, design control, and managing software releases. The working model is hybrid, requiring regular onsite presence while allowing for collaboration with global teams.

Qualifikationen

• Background in Computer Engineering or similar technical field
• Solid experience with software-intensive medical devices
• Proven ability to apply IEC 62304 in development environments

Aufgaben

• Drive technical maturation and release of AI-powered software
• Collaborate with Project Managers and Release Managers
• Support regulatory submissions and audits

Kenntnisse

Experience with medical devices

Design control

Requirements management

Risk management

Collaboration skills

English fluency

Ausbildung

Degree in Computer Engineering, Software Engineering, or similar

Tools

IEC 62304

ISO 14971

MDR/FDA guidelines

Jobbeschreibung

Release Engineer / Technical Lead, Software & Electronics – AI & Machine Learning

Do you want to apply your engineering skills in a global MedTech company currently disrupting the endoscopy market? Would you like to take a leading role in bringing regulated AI solutions safely and efficiently into clinical use?

In this exciting position, you will be an active contributor shaping the future of Ambu’s Endoscopy Systems and AI‑powered solutions. You will report to the Head of Endointelligence Release and join a highly engaged team of Release Engineers, Release Managers, Process Owners, and System Architects working at the heart of Ambu’s software and system releases.

The position is based in Augsburg, while you will collaborate closely with colleagues across Ambu’s global innovation sites, particularly in Ballerup and Penang. You will be part of a global Software & Electronics organization, working with software developers, AI specialists, UX designers, testers, and electronics engineers.

We offer a hybrid working model, while also valuing close collaboration and teamwork. As a result, a regular presence at the Augsburg Site is required, as in‑person interaction plays an important role in our daily work.

If you are motivated by meaningful work, enjoy collaborating in an international environment, and want to contribute to improving patient care, we would be happy to hear from you.

Shaping the future of AI‑powered Endoscopy Solutions

Ambu’s Endoscopy Systems are advanced platforms combining software, electronics, and intelligent algorithms to support clinicians in delivering high‑quality patient care. With the introduction of AI‑ and ML‑based functionality, our solutions are expanding from image and video presentation to intelligent workflow support.

As Release Engineer / Technical Lead for one of our key AI initiatives, you will play a central role in ensuring that innovative AI technology is developed, integrated, documented, and released in a way that is safe, compliant, and scalable. You will work at the intersection of technology, design control, and regulation, ensuring that product and system maturity matches Ambu’s quality and patient safety ambitions.

In this role, you will be involved in all phases of the product lifecycle – from early concept and architectural decisions through development, verification, regulatory submission, market release, and sustained lifecycle management. You will combine deep technical understanding with a strong design control discipline, acting as the technical anchor between AI/ML developers, system engineers, quality, regulatory affairs, and project management.

Two days will rarely look the same, but your work will consistently focus on driving technical clarity, risk awareness, and release readiness of complex AI‑enabled systems.

Key tasks & responsibilities

• Act as Release Engineer / Technical Lead for one of Ambu’s core AI/ML initiatives, providing technical direction and ensuring alignment across software, algorithms, systems, and regulatory requirements.
• Drive the technical maturation, integration, and release of AI‑powered software features into Ambu’s Endoscopy Systems.
• Own and maintain design control deliverables, including requirements definition and traceability, system and software documentation, and translating clinical, business, and regulatory needs into robust technical requirements.
• Ensure compliance with relevant standards and regulations such as IEC 62304, SaMD, ISO 14971, MDR/FDA requirements, and emerging AI‑related guidance and standards (e.g., AI/ML lifecycle management, data management).
• Establish and maintain technical and documentation overview across system interfaces, software components, data pipelines, and model lifecycle aspects.
• Support regulatory submissions and audits, ensuring that documentation is complete, consistent, and aligned with Ambu’s QMS.
• Drive lifecycle management activities, including design changes, product updates, NCRs, and CAPAs for marketed systems.
• Collaborate closely with Project Managers, Release Managers, Product Managers, Product Owners, AI/ML developers, testers, UX, and external partners to ensure successful delivery.
• Contribute to the continuous improvement of processes, templates, and ways of working supporting AI and software development in a regulated environment.

Your contact base is broad, and you will collaborate with Ambu’s global organization, all departments involved in product development projects and external technical partners and suppliers, so some travel (15‑20%) is expected with this position.

Suggested candidate profile

• An educational background within Computer Engineering, Software Engineering, Computer Science, Electrical Engineering, or similar technical field.
• Solid experience with software‑intensive medical devices or other regulated products.
• Strong hands‑on experience with design control, requirements management, risk management, and traceability.
• Proven ability to apply IEC 62304, ISO 14971, MDR/FDA guidance in practical, iterative development environments.
• Experience working with or close to AI/ML development (e.g., as a system engineer, software engineer, algorithm developer, or technical lead).
• Understanding of AI‑specific challenges such as data dependency, model performance, validation, change management, and lifecycle maintenance in regulated products.
• Experience with system integration and complex hardware/software/software interactions.
• Strong analytical skills and the ability to balance technical depth with product‑level decision‑making.
• The ability to work independently, structure complex work, and proactively drive progress across many stakeholders.
• Excellent collaboration and communication skills in a global, cross‑functional environment.
• Experience as a software or algorithm developer is a strong advantage, but not a requirement.

As Ambu is a global company, it is important that you communicate fluently in English both written and spoken.

About Ambu

Ambu is a global MedTech company and a market leader in single‑use endoscopy. We are growing rapidly and driven by ambitious goals, enabled by close interdisciplinary collaboration and a strong quality mindset.

At Ambu, your work matters. You will have real influence on products used by millions of patients worldwide, and you will be supported by an informal, professional work environment with strong opportunities for personal and professional development.

We will invite candidates for interviews on a continuous basis. Don’t hesitate to apply.

Your application will be treated confidentially.