Germany
Usability engineer with a PhD in Human–Machine Interaction, focused on developing safe and user-centered healthcare technologies. Experienced in human factors engineering, risk-based design, and regulatory compliance (MDR/FDA) across medical device development. I work closely with R&D and quality teams to integrate user needs and safety into product lifecycles.
-Generation of Human Factors Engineering documents throughout the product lifecycle (including Use Specification, Known Use Problems, Task Analysis, User Interface Specification). -Input into the use-related aspects of the risk management process (including Use-Related Risk Analysis, uFMEA, Benefit-Risk Analysis, Risk Management Report). -Creation of HF processes and ensure compliance to the latest HF/usability standards and guidances (IEC 62366, FDA HF Guidance, “Applying Human Factors and Usability Engineering to Medical Devices Guidance for Industry and Food and Drug Administration Staff” etc.). -Validation testing of Dry Powder Inhalers and nebulisers. - Working knowledge of ISO 14971 Risk Management standard for medical devices, 21CFR820.30, Design Controls, EN ISO 13485. -Prepare and review documentation for submission to regulatory agencies and notified bodies. - User Support Materials (IFU, Labelling etc.) development and testing. -Input into Clinical Evaluation Report.
- Completed 16 courses from MSc and PhD level mainly about production and human factors - Learned and improved statistical and design skills with R, Minitab, and Siemens JACK - Conducted Usability Testing: Investigated and communicated current and future user needs and expectations. - Specialised in using DHM software (JACK) to complete digital user fitting studies for Human-Robot-Collaboration environment. - Assessed mental workloads of 23 students with NASA-TLX method. - Assessing Human Computer Interface with IBM CUSQ and technology acceptance methods.
• Scheduled material deliveries and production usage of materials for optimal production. • Analytical determination of re-order points, backorder recovery and safety mechanisms. • Used MRP, Kanban system and Order based planning methods • Reviewed production schedules to establish material safety stock and target inventory levels for materials