System Architect (Principal)

System Architect (Principal) – Shape the Future of Medical Device Innovation Would you like to help drive the transformation from product-centric to platform-centric development in global innovate medtech company? Then we offer you an opportunity to join a highly skilled R&D environment where collaboration, learning, and innovation go hand in hand. Your role will drive how we work with system architecture, requirements, modularization, and platform building across the organization – while contributing to products that make a difference for our users every day. At Coloplast, we work every day to improve the lives of people with intimate healthcare needs. And you will play a key role in bringing our strategy to life by helping shape the future of how we develop innovative medical devices. Join a team shaping the future of R&D You will become part of our Requirements Engineering Team, which forms an essential part of our new Centre of Excellence in R&D, bringing together almost 500 talented colleagues. In your new team, you will meet 7 colleagues who are global process owners of regulated medical device processes and our system architects driving our large strategic development projects. Together, we define and improve ways of working across R&D to enable ambitious innovation to reach our users faster through a more structured and scalable development approach. And of course, we make sure to have fun along the way. Lead the development of the System Architecture discipline As our new Principal System Architect, you will lead the development of the system architecture discipline and help position it for the future. This means you will lead Coloplast’s journey from developing individual products towards platform building and building up competences within system architecture discipline. Specifically, you will:

• Lead and support the implementation of platform-based product development and manufacturing process development.
• Strengthen and mature the system architecture discipline by defining and evolving processes, methods, and best practices.
• Contribute to building system architecture capabilities across the organisation through training, sparring, coaching and knowledge sharing.
• Shape and communicate the value of system architecture as part of ongoing transformation initiatives.
• Build alignment across stakeholders in a complex, cross-functional environment by engaging, listening, and creating shared understanding.
• Driving results through colleagues, including other system architects, project managers, program managers and system engineers, in a motivating and engaging way.
• Contribute hands-on to development projects as a trusted architecture resource, working closely with teams to define and deliver system architecture artefacts (e.g. system design, interface specifications, functional analysis and impact analysis)
• Translate inputs from across the business (e.g. commercial, regulatory, manufacturing) into clear and usable system architecture decision and artefacts, ensuring different perspectives are reflected
• Ensure system architecture is effectively integrated with related development disciplines such as requirements engineering, test, and documentation management

Solid Experience In System Architecture For Physical Product Development You are a team player, with strong communication skills and the ability to communicate clearly and concisely as you manage stakeholders across a complex and large organization. Moreover, you have the ability to balance and consider cross-functional concerns in decision-making, and you take a coaching leadership approach to support and develop colleagues and stakeholders. While experience from the medical device industry is valuable, we also welcome candidates with a strong systems engineering and architecture background from other complex product development industries such as aerospace, defense, industrial automation, robotics, windmill industry or advanced consumer products. What We Expect From You

• 7+ years of experience in system architecture, preferably for physical products and hardware-based systems, not solely software.
• Strong stakeholder management skills and a proven ability to drive alignment across functions, disciplines, and organizational levels.
• Comfortable working across engineering, product management, quality, regulatory, manufacturing, and other key functions.
• Experience leading or influencing organizational change, including the implementation of new ways of working, processes, or engineering practices.
• Ability to provide technical leadership, coaching, and architectural guidance to teams and stakeholders.
• Extensive hands-on experience with systems engineering for complex products, including system architecture, requirements management, interface management, verification, and validation.
• Proven experience establishing, evolving, and governing system architecture and systems engineering practices.
• Experience with modular architecture, product platforms, and reusable architecture strategies.
• Strong knowledge and practical application of systems engineering principles, methods, and best practices, including recognized industry frameworks such as INCOSE.
• Experience contributing directly to development projects and delivering architecture artefacts from concept through implementation.
• Proven experience operating in regulated product development environments and balancing technical, quality, risk, regulatory, and design control requirements.
• Ability to translate diverse business, user, and technical needs into clear architecture decisions and system-level solutions.
• Strong architectural judgement and ability to balance commercial, technical, regulatory, manufacturing, and user considerations.
• Experience defining system boundaries, interfaces, and reusable architectural building blocks that support platform-based product development.
• Motivated by both shaping long-term architectural direction and contributing to successful day-to-day product delivery.

You might also bring

• Experience from medical device development or other highly regulated industries.
• Knowledge of relevant standards and frameworks such as ISO 13485, ISO 14971, IEC 62304, IEC 62366, or equivalent.
• Understanding manufacturing, industrialization, and production processes, ensuring architectures are scalable, manufacturable, testable, and cost-effective throughout the product lifecycle.
• Experience supporting product strategy through platform thinking, technology roadmaps, and long-term architecture planning.

Please note: Seniority level will be determined based on your experience (principal, senior principal) Interested? If you would like to know more about this position, please contact Head of Requirement Engineering, Centre of Excellence, R&D, Stine Renberg at +45 49113320. We continuously review applications, so we encourage you to apply as soon as possible. The position will remain open until a suitable candidate is found. Please note: Stine is back from holiday 27th July. 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. Watch the film. Follow us on LinkedIn. 61626