Global Process Lead - Product Design and Engineering Data 1

Ambu; Augsburg; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Ambu is seeking a Global Process Lead – Software Development to join our Innovation PMO. You will shape how we develop software for medical devices and AI functionality within a global, cross-functional team.

This senior role focuses on owning Software Development processes in the Quality Management System, driving process improvements, and ensuring regulatory compliance across SaMD/SiMD. If you bring 7+ years in MedTech software, strong governance, and excellent English communication, you will

Qualifications

• 7+ years of software development experience in the MedTech industry.
• Ability to drive new process initiatives with strong stakeholder management.
• Strong regulatory and quality requirements knowledge for medical device software, incl. AI.
• Experience delivering software under regulatory requirements with short time to market.
• Experience using governance to steer software development in this setting.
• Fluency in English.
• Excellent communication, collaboration and presentation skills.
• Quality, efficiency and optimization mindset.
• Knowledge of ISO 62304 and ISO 13485.

Responsabilités

• 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) including AI functionality.
• Improving and maintaining the Software Development processes for efficacy, efficiency and compliance while integrating with R&D processes.
• Audit preparation and support regarding the Software Development processes.

Connaissances

MedTech software

Stakeholder management

Regulatory knowledge

AI functionality

Governance

English fluency

Communication skills

Quality mindset

ISO 62304 / ISO 13485

Description du poste

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:

Skills

• 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.