Systems/Release Engineer / Technical Lead

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Ambu A/S is seeking a Systems/Release Engineer and Technical Lead in Augsburg to drive design control, requirements management and release readiness for software-intensive medical devices within a global software and electronics organization. You will translate user and regulatory needs into robust requirements, maintain end-to-end traceability, and lead cross-functional teams across software, hardware, quality and regulatory affairs while ensuring IEC 62304 ISO 14971 MDR and FDA compliance. The role includes 15 to 20 percent travel, hybrid onsite work, and collaboration with teams in Denmark and Malaysia. Applicants should have an engineering degree and proven experience in regulated environments with systems engineering and release leadership; AI experience is a plus. Apply by showcasing regulatory acumen, release governance, concrete outcomes, and strong stakeholder collaboration, plus willingness for on-site presence in Augsburg.

Systems/Release Engineer -Technical Lead

Shaping the future of AI-powered Endoscopy Solutions 

Ambu's Endoscopy Systems combine software, electronics, user-focused design, and advanced technologies to support clinicians in delivering high-quality patient care.

Reporting to the Head of Endointelligence Release, you will join a highly engaged and supportive team of Systems Engineers, Release Engineers, Release Managers, Process Owners, and System Architects working at the heart of Ambu's software and system development activities.

The position is based in Augsburg, Germany, where close collaboration with local colleagues is an important part of the role. At the same time, you will work closely with teams across Ambu's global innovation organization, particularly in Ballerup (Denmark) and Penang (Malaysia).

We offer a hybrid working model that provides flexibility while maintaining strong team collaboration. As much of the role involves cross-functional stakeholder management, technical discussions, and system-level decision-making, a regular presence at our Augsburg site is expected.

As part of Ambu's global Software & Electronics organization, you will collaborate with software developers, system architects, quality and regulatory specialists, product managers, and technical experts across multiple locations.

Some international travel (approximately 15–20%) should be expected to support project activities, stakeholder alignment, workshops, and collaboration across Ambu's innovation sites.

As a Systems Engineer / Release Technical Lead, you will play a key role in ensuring that complex software-intensive products are developed, integrated, documented, and released in a safe, compliant, and scalable way. Working at the intersection of systems engineering, software development, quality, and regulatory affairs, you will help drive technical maturity throughout the product lifecycle.

While the role supports one of Ambu's strategic AI-enabled initiatives, your primary focus will be systems engineering, design control, requirements management, technical leadership, and release readiness.

You will work closely with software developers, system architects, product managers, quality and regulatory specialists, ensuring that business, clinical, and regulatory requirements are translated into robust product solutions.

No two days are the same, but your work will consistently focus on creating technical clarity, managing complexity, and helping teams successfully bring innovative products to market.

Key tasks & responsibilities   

Your main responsibilities will include:

• Acting as Technical Lead and Release Engineer for software-intensive medical device projects.
• Driving requirements definition, system-level thinking, design control activities, and release readiness.
• Translating user, business, and regulatory needs into clear, testable technical requirements.
• Ensuring end-to-end traceability across requirements, risks, verification activities, and product documentation.
• Supporting compliance with relevant standards and regulations, including IEC 62304, ISO 14971, MDR, FDA requirements, and Ambu's Quality Management System.
• Maintaining system-level understanding across software, hardware, interfaces, and product architecture.
• Supporting regulatory submissions, audits, and design reviews.
• Driving lifecycle management activities, including design changes, product updates, NCRs, and CAPAs.
• Collaborating closely with software developers, system architects, quality, regulatory affairs, project managers, and external partners.
• Contributing to the continuous improvement of processes, tools, and ways of working within software and systems development.

Suggested Candidate Profile

Skills and experience can be gained in many ways, and we know the perfect profile cannot be prescribed on paper. You are, however, likely to succeed in this role if you bring many of the following:

• A degree in Engineering, Computer Science, Physics, or another relevant technical discipline.
• Experience developing complex products in a regulated environment, ideally within MedTech, but candidates from other regulated industries are also encouraged to apply.
• Experience with systems engineering, requirements management, design control, risk management, verification, and traceability.
• Familiarity with relevant standards and regulatory frameworks such as IEC 62304, ISO 14971, MDR, FDA requirements, or equivalent industry standards.
• Experience working with complex systems involving software, hardware, electronics, and multiple stakeholders.
• Strong analytical skills and the ability to balance technical details with broader product objectives.
• A structured and proactive approach to driving progress in complex development environments.
• Excellent collaboration and stakeholder management skills.
• Exposure to AI-enabled products, advanced software solutions, or data-driven systems is considered an advantage, but is not required.
• Experience as a software developer, systems engineer, technical lead, or product development engineer would be beneficial.

Ambu – a visionary and international workplace 

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. 

Join the team!    

We will invite candidates for interviews on a continuous basis so don't hesitate to apply.   

Your application will be treated confidentially.