Senior Software Systems Architect

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Senior Software Systems Architect

Do you have a passion for software as a medical device (SaMD), SW systems architecture, Connectivity (BLE), SW design and solving complex problems in this relation? Would you like to work with highly experienced product developers and specialists?

 

As you read this, we are working on releasing our first medical device software connected app in compliance with IEC 62304. As a Senior SW Systems Architect for medical device app development and maintenance, you will understand the full end to end SW system architecture including dependencies to hardware and embedded components; cloud backend solutions and native mobile operating systems (iOS and Android). You will partake in launching the app to multiple markets, ensuring the continuous improvement of the system, So, grab this opportunity to make a real life-changing difference for people with intimate healthcare needs and join us in taking the next steps in our exciting journey.

 

Work with an international team of brilliant minds

In Humlebæk, you will join the Digital, Data and IT department as part of our Agile Delivery team which consists of highly skilled techies and SaMD people. We deliver through a Program Structure of multiple digital teams, and your daily work will be working in one of these teams, delivering on the roadmap for an embedded medical device SW product.  

 

Working with us, you will have plenty of opportunity to create value – among others, you will work closely with a full stack DevOps team consisting of scrum master, product owner, project manager, test manager, risk manager, systems engineers, developers etc. One of your closest colleagues will be our Sr. SaMD Product Owner. 

 

“You will play a key role in friendly and ambitious team with colleagues in Humlebæk, and with team members in other locations in Europe. We are striving to make agile development and compliance to medical device regulations go hand-in-hand and are looking for a colleague to become even better”.

– Claus, Sr. SaMD Product Owner.

 

Participate in projects and ensure optimal processes
As you partake in releasing the medical device connected mobile app, defining, and driving product development and device life cycle processes internally and externally with vendors, you will function as the key internal SW Systems Architect. More specifically, you will collaborate closely with the SW development team, quality and regulatory specialists, and Business- and IT Stakeholders across the company as you:

 

• Design and implement the connected app SW System architecture to be scalable and that meets both consumer and business needs.
• Work closely with the core SW development team on a daily basis to create safe and reliable medical device software of high quality.
• Collaborate with the cross-functional team and other stakeholders (such as embedded systems team, quality assurance and regulatory affairs specialists) to define and specify requirements for the SW system.
• Analyse and define design specifications that implement the SW architecture.
• Plan and support the SW/App release, review and document the technical solution and the individual releases in compliance with best practices and requirements from relevant standards, such IEC 62304, ISO 14971.
• Continuously identify opportunities for improving our SW architecture and processes to ensure that they are complying while promoting effective ways for working resulting in safe SW of high quality.
• Facilitate design input analysis workshops.
• Provide training and advisory within medical device software development and maintenance processes to the team.

 

A background in the development of complex technical solutions
To succeed in this role, you will need curiosity, drive, persistence and a passion for new technologies, connectivity and SW systems. You like