Software Process Owner
Do you aspire to improve Medical Device Software development processes to ensure they are compliant, but also effective and efficient to help our developers to deliver innovative solutions that help patients worldwide? Do you thrive by familiarizing yourself with new topics and collaborating with stakeholders as well as subject matter experts to influence and define our ways of working?
Then you might be the new Software Process Owner at Ambu!
Shaping the future of Endoscopy Systems
Endoscopy Systems are used by healthcare professionals to examine the interior of a body organ or cavity. The endoscopy system enables healthcare professionals to see the internal structures while being able to use a wide range of software features, including video recording, image adjustments, etc. With Ambu’s increasing focus on developing new software to enhance the functionality of our endoscopy systems, including the introduction of artificial intelligence, this position will be pivotal.
In this position, you will be responsible for the software process within our Quality Management System and be responsible for ensuring that it supports Ambu’s digital journey. You will ensure that our Medical Device Software development processes are compliant, effective and efficient supporting our developers in delivering innovative solutions to our customers.
You will join an enthusiastic team of experienced professionals with various backgrounds who ensure that new software and new compatible endoscopes get released on the endoscopy systems while remaining safe and efficient. Meanwhile, You will collaborate with subject matter experts and help guide them on how to describe their development work and you will work with the Innovation Process Solution team to ensure our procedures fit into our Quality Management System.
Key responsibilities
Your main responsibilities will include:
* Ensure processes comply with medical device regulations and standards, including IEC 62304, ISO 82304-1, ISO 13485, ISO 14971, and emerging AI-related guidance (e.g., FDA Good Machine Learning Practices, EU AI Act considerations).
* Define and monitor Medical Device Software Process metrics and KPIs, identify gaps and drive corrective actions and preventive actions.
* Support teams in process adoption through training, coaching, templates, and documentation guidance (SOPs and quality handbooks).
* Collaborate with cross-functional teams including R&D, Quality Assurance, and Regulatory Affairs to gather necessary information and ensure accuracy and completeness of documentation.
* Ensure that Software procedures and Quality Handbooks remain effective, efficient and current and compliant with standards and regulations.
* Design Control documentation both for ongoing projects but also for already released products.
* Participate in internal and external audits as the subject matter expert for our Medical Device Software Process.
Suggested candidate profile
Skills and experiences can be earned in many 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:
* Hold a Bachelor’s or Master’s degree in Computer Science, Engineering, Life Sciences, or related field.
* Have 8+ years of experience in software development in the medical device or healthcare technology industry.
* Have 5+ years of experience writing standard operating procedures for Medical Device Software.
* Have proven experience with medical device regulations (EU MDR, FDA), quality systems (ISO 13485), and software lifecycle standards (IEC 62304).
* Have been working with Software as Medical Device (IEC 82304) and ideally including AI functionality is an advantage.
* Have proven experience with process ownership and software process governance.
* Are mastering agile methodologies (Scrum, SAFe, LeSS, or similar) in a Medical Device context, like AAMI:TIR45.
* Have a mindset for quality, efficiency and optimization and thrives with structure and rules.
* Are open-minded and eager to drive the creation, update and implementation of processes for new software development.
* Excellent written and verbal communication skills in English.
You have excellent interpersonal skills, such as:
* Exceptional stakeholder management and communication skills.
* Great planning, scheduling, and prioritization capabilities.
* Strong analytical thinking, problem-solving, and decision-making skills.
* Flair for fostering collaboration, accountability, and transparency across diverse teams.
Ambu – a visionary and international workplace where your efforts matter
Ambu is a leading multinational medical device company dedicated to improving patient care through innovative solutions. With a strong focus on research and development, Ambu designs and manufactures high-quality medical devices that enhance the efficiency and effectiveness of healthcare professionals. Today, more than 100 million patients worldwide depend on the efficiency, safety and performance of our innovative solutions, and we are committed to maintaining the highest standards of quality and compliance
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. If you are ready to apply for the position, please apply as soon as possible. We will invite candidates for interviews on a continuous basis so there is no need to hesitate.