LOCATION:

Humlebæk, DK
Job Family: Information Technology
Country/Region: Denmark
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 to keep up to date with new technologies and are not afraid of challenging the status quo.
Moreover, you can voice your ideas and navigate in an environment where years of habits and processes are being replaced by new, agile development initiatives. Striking the right compromises and getting stakeholders on board in that transition phase will take solid communication skills.
As a colleague, you are a team player with a can-do attitude, and a fast-paced, exciting, and fun environment suits you perfectly.
Ideally you have a BSc/MSc in IT, or engineering e.g. from ITU or DTU.
5+ years of experience with software solution design, development, and operations – preferably using Microsoft Azure DevOps.
Experience with developing great SW system architecture for embedded solutions or and downstream systems
Experience in SCRUM/Agile development, preferably within the SAFe framework.
Experience with software development in the medical technology industry, preferably regulated by e.g. IEC 62304.
Experience with mobile app solutions, cloud frameworks and embedded technologies.
Have great communication and collaboration skills. Good at communicating complex matters in a simple and clear manner.
Understand the value of seeing the larger perspective while excel at breaking down delivery into smaller increments to provide value.
You speak and write English fluently.
Interested?
Don’t hesitate to apply. We encourage applications from suitably qualified and eligible candidates.
If you want to know more about the position, you can reach out to the Head of Agile Delivery, Dina Bjørn Andersen dkdiba@coloplast.com. We will take candidates into the recruitment process continuously, so do not hesitate to apply. This position will remain open until a suitable candidate has been found.

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Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 14.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.
Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.
Visit us on Coloplast.com.
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Please refer the Job description for details