Global Process Lead - Software Development

Ambu A/S; Augsburg; On-site; EUR 90,000 - 120,000; Full time

Job summary

Ambu is seeking a Global Process Lead – Software Development to join its Innovation PMO in Augsburg. You will own software development processes, drive SaMD/SiMD initiatives, and ensure regulatory alignment across ISO 62304 and ISO 13485.

The role requires English fluency, over 7 years in MedTech software, and strong stakeholder collaboration. Join a global, high-performing MedTech company that values quality, efficiency and continuous improvement, with opportunities for international

Qualifications

• 7+ years of software development experience in MedTech.
• Strong stakeholder management skills.
• Deep understanding of regulatory and quality requirements for medical device software, including AI.
• Experience delivering software under strict quality and time-to-market pressures.
• Knowledge of ISO 62304 and ISO 13485.

Responsibilities

• Own Software Development processes in the Quality Management System.
• Drive development of SaMD/SiMD software processes including AI.
• Improve and maintain processes for efficacy, efficiency, and regulatory compliance.
• Assist with audit preparation and support for Software Development processes.

Skills

MedTech software

Regulatory knowledge

AI functionality

Stakeholder management

ISO 62304

ISO 13485

Job description

Global Process Lead - Software Development

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Global Process Lead - Software Development City: Augsburg Country/Region: Germany State: Business Area: R&D Department: Innovation PMO Employment Type: Full-time Req ID: 10633

Are you passionate about solving problems and developing smart solutions? Do you enjoy working in an international environment and would you like to join one of the best performing MedTech companies in the world right now? Then this might be your defining moment!

Ambu is currently looking for a Global Process Lead – Software Development to join our global Innovation PMO Department.

In our team, we have a diverse group of experienced Innovation Process Specialists across three countries, each with their own expertise, but with the common goal of creating and improving effective and efficient processes for the development and maintenance of our medical-device products.

In this senior position, you will bring your expertise to strengthen our team and play a central role in shaping the way Ambu develops software for medical devices.

Key responsibilities

Your main responsibilities will include:

• Ownership of Software Development processes in our Quality Management System
• Driving the development of Software Development processes for software as/in a medical device (SaMD/SiMD) and including AI functionality
• Improving and maintaining the Software Development processes in terms of efficacy, efficiency and compliance while ensuring that it integrates with the rest of R&D processes
• Audit preparation and support regarding the Software Development processes

Suggested candidate profile

Skills and experiences can be earned in many different ways, and we understand that the best fit for the role cannot be prescribed on paper. You are however likely to succeed in this position if you have:

• Over 7 years of experience within software development in the MedTech industry
• The ability to efficiently drive new process initiatives with strong stakeholder management
• A comprehensive understanding of the regulatory and quality requirements when developing software for a medical device, as a medical device and ideally including AI functionality
• Experience in how software can be developed according to these requirements with a short time to market
• Experience in utilizing governance to steer the development of software in said setting
• Fluency in English
• Excellent communication, collaboration and presentation skills
• A mindset for quality, efficiency and optimization
• Knowledge of ISO 62304 and ISO 13485.

Ambu – a visionary and international workplace where your efforts matter

Ambu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us you will get the opportunity to work in an international head office with an informal working environment.

We offer great opportunities for personal development. Furthermore, we offer a wide range of professional, social and financial employee benefits in addition to exciting job challenges and continuous professional and personal development.

When to apply

As an equal opportunity employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.

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 .