Systems/Release Engineer / Technical Lead

Ambu A/S; Augsburg; Hybrid; EUR 70.000 - 120.000; Vollzeit

Zusammenfassung

Ambu is seeking a Systems/Release Engineer – Technical Lead in Augsburg, Germany, with a hybrid work setup. You will join a multidisciplinary team driving design control, release readiness, and cross-functional collaboration to deliver AI-enabled medical device software and systems.

You will translate regulatory requirements into robust technical specifications, manage end-to-end traceability, and support regulatory submissions, audits, and design reviews while leading lifecycle management and

Qualifikationen

• Experience in regulated environments (MedTech preferred).
• Strong systems engineering and requirements management expertise.
• Familiarity with IEC 62304, ISO 14971, MDR, FDA requirements.

Aufgaben

• Act as Technical Lead and Release Engineer for software-intensive medical device projects.
• Drive requirements definition, system-level thinking, design control, and release readiness.
• Translate user, business, and regulatory needs into clear, testable technical requirements.
• Ensure end-to-end traceability across requirements, risks, and verification activities.
• Support compliance with relevant standards and regulatory frameworks.
• Maintain system-level understanding across software, hardware, interfaces, and product architecture.
• Support regulatory submissions, audits, and design reviews.
• Drive lifecycle management activities including design changes, NCRs, and CAPAs.
• Collaborate with software developers, system architects, quality and regulatory teams, and external partners.
• Contribute to continuous improvement of processes and tools.

Kenntnisse

Systems engineering

Requirements management

Design control

Risk management

Verification

Traceability

Regulatory understanding

Cross-functional collaboration

Ausbildung

Engineering degree (Engineering / Computer Science / Physics)

Tools

PLM systems

Jobbeschreibung

Systems/Release Engineer / Technical Lead

City: Augsburg Country/Region: Germany State: Business Area: R&D Department: EndoIntelligence Release Employment Type: Full-time Req ID: 10167

Systems/Release Engineer -Technical Lead

Shaping the future ofAI-powered EndoscopySolutions

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.

You enjoy bringing structure and clarity to complex product development projects. With expertise in design control, requirements management, traceability, and release processes, you excel at working in PLM systems, driving standardization, and coordinating stakeholders across software, systems engineering, quality, and regulatory affairs.

Keytasks & 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 haverealinfluence 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.

Your application will be treated confidentially.

About Ambu

Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.

For more information, please visit ambu.com or follow us on LinkedIn .