Experience should include HF/UE activities conducted in accordance with IEC 62366-1 and FDA HF/UE guidance; Experience integrating use-related risk analysis into HF/UE planning, validation strategy, and product development decision-making for regulated medical devices or combination products; Experience contributing to HF/UE submissions and supporting interactions with regulatory bodies, especially with the US FDA; Solid background in user-centric design, design controls (CFR 820.30, ISO 13485), risk management (ISO 14971), EU MDR, and requirements engineering; Patient/user advocacy with a solution-oriented mindset; Strong communication and collaboration skills in English; Ability to work effectively in a dynamic global matrix environment, embracing change and supporting team decision-making. In this role, you will work at the interface between patients/users, product leadership, commercial, medical/clinical, and engineering teams, contributing to the design of medical devices and drug-device combination products that enhance safety, effectiveness, and the user experience.