In this role, you will shape the human factors strategy for medical products to optimize user experience and patient outcomes. You will collaborate with cross-functional teams to integrate HF into product design and lifecycle management, ensuring compliance with ISO, FDA and MDR requirements. You will lead external partners in HF studies and drive documentation from task analysis to final reports. This position offers a chance to contribute to safer, user-centered medical devices in a dynamic, international environment.

- 5-8% variable premio/MBO
- private health insurance
- pension fund
- salary based on experience and internal equity
- career progression and compensation reviews
- Define user requirements and translate them into product solutions to improve user experience
- Develop and own the Human Factors strategy and documentation for HF files
- Coordinate and manage external partners conducting HF studies under a risk-based approach
- Lead preparation of task analyses, formative and summative studies, usability risk assessments, HF plan and final reports




- Ensure HF activities are integrated into design development from feasibility to lifecycle management
- Apply design control principles and participate in activities like product risk management, requirements definition, testing (DVT), and equipment validation (IQ/OQ/PQ)
- Degree in Biomedical Engineering, Design, HFE or related fields
- 1+ year of experience in HFE and medical product development
- Knowledge of user-centered design and usability engineering
- Experience generating HF usability documentation (URRA, usability study docs)
- Strong collaboration with cross-functional teams (engineering, regulatory, quality, etc.)
- Experience with all phases of medical device product development under a QMS
- Knowledge of IEC 62366, FDA HFE guidelines, ISO 13485, ISO 14971, ISO 14971?
- Design control guidance under FDA and MDR

In this role, you will shape the human factors strategy for medical products to optimize user experience and patient outcomes. You Will coll

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📌 Human Factor Engineer (Milano)
🏢 Experteer Italy
📍 Milano