Principal System Architect – Medical Device Innovation

About the role

Join Coloplast’s R&D Centre of Excellence as a Principal System Architect and drive the shift from product‑centric to platform‑centric development of medical devices. You will shape system architecture, modularisation and platform strategies across the organisation, contributing to products that improve users' lives.

Key responsibilities

• Lead the implementation of platform‑based product and manufacturing processes.
• Define, evolve and govern system architecture processes, methods and best practices.
• Provide training, coaching and knowledge sharing to build architecture capability.
• Translate commercial, regulatory and manufacturing inputs into clear architecture decisions and artefacts.
• Collaborate with requirements engineering, test and documentation teams to ensure integrated development.
• Contribute hands‑on to projects, delivering system design, interface specifications and impact analyses.

Required profile

• 7+ years of experience in system architecture for physical, hardware‑based products.
• Strong stakeholder management and ability to align cross‑functional teams.
• Proven experience leading organisational change and new ways of working.
• Hands‑on systems engineering expertise, including verification and validation.
• Experience in regulated environments, balancing technical, quality and risk requirements.

Required skills

• System architecture and modular platform development.
• Requirements management, interface management, verification and validation.
• INCOSE systems engineering framework.
• Knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 62366.
• Hardware‑centric product development (aerospace, industrial automation, robotics, etc.).