Software Systems Engineer - develop software for medical devices

Humlebæk, DK

Job Family: Information Technology

Country/Region: Denmark

Coloplast has successfully launched the world’s first leakage notification system, our Heylo app. And now, we are gathering colleagues in a team dedicated to medical device software innovation.

Join us to support our Heylo app and the future innovation pipeline within medical device software development. And be part of making a real difference for people with intimate healthcare needs – who have already given us great feedback on our first digital release.

A new team – of experienced and knowledgeable colleagues
Based out of the Coloplast Headquarters in Humlebæk, you will be part of Digital Data and IT and our eCommerce & Digital Solutions department. Within this department, we are now building Digital Health consisting of 6 colleagues focusing on innovating medical device software.

Along with the rest of your team, you will be key in ensuring that we work continuously towards a lean and efficient design and development process striving towards automation.

Translate requirements into design specifications
You will be working closely with R&D, Regulatory Affairs, Global Quality and the rest of Digital Data & IT on medical device software development and software bundle releases. Specifically, you will be responsible for translating requirements into design specifications that can be implemented into working software that is verifiable. Your aim is to structure project documentation and traceability to support efficient software design and development processes while being in regulatory compliance.

While ensuring effective communication and reference of software product design for key stakeholders in e.g. R&D, RA, QA, and Operations, you will also:

• Facilitate requirements specification activities and documentation to ensure traceability
• Ensure that design development and maintenance of medical device software comply with relevant standards, such as IEC62304 specifically, and related standards for medical devices
• Work closely with our product owner and system architect and the rest of the development team to ensure quality designs descriptions that implement requirements and are ready for implementation and verification
• Collaborate with cross-functional teams to integrate automated documentation processes into the development lifecycle.

Software development experience and an understanding of industry standards
In this role, you need good stakeholder management skills, allowing you to translate technical requirements and communicate decisions, regulatory as well as technical designs to different colleagues. And you make sure to document technical discussions to ensure product quality. Moreover, even though we work according to SAFe and agile principles, you need to be okay with plans changing as we work with innovation.

Finally, we imagine that you:

• Hold a degree in Computer Science, Software Engineering, or similar
• Have some years of experience with software development
• Have experience working with medical device software, following industry standards like IEC62304, ISO14971, ISO13485 and design control processes
• May have experience with automation tools (e.g., Python, scripting languages), though this is only a plus

Interested?
If you would like to know more about the position, please contact Claus Cramer-Petersen, Senior Digital Product Owner via [email protected]. 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.

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16.000 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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