Applications Engineer programming and leading projects for Smart Grids within Ormazabal's Digital Hub. Seeking a passionate individual to join a leading innovative company.
About the role
- Human Factors & Usability Engineer working on medical device usability studies and risk analysis. Collaborating with cross-functional teams and supporting regulatory submissions for user-centric design.
Responsibilities
- Conduct early-stage generative research to discover user needs, contexts of use, and unmet needs
- Execute user characterization studies to explore the capabilities, limitations, and variability of intended user populations
- Perform functional task analysis, use-related hazard analysis, and known use problems analysis
- Apply good study design to enable iterative UI design leveraging a range of research and testing methods
- Conduct use error analysis and root cause analysis
- Translate study results into user needs, design recommendations, and UI specifications
- Develop study protocols and execute summative validation studies
- Support regulatory submissions and health authority interactions
Requirements
- Bachelor's degree in human factors, psychology, biomedical engineering, or related field
- 2.5 to 5 years applying human factors engineering to medical devices or combination products
- Health Authority & Standards knowledge of relevant FDA HF Guidance documents, IEC 62366-1:2015+A1:2020, ISO 14971:2019, ISO 13485, EMA guidelines
- Strong cross-functional collaboration and communication skills (written and spoken English)
- Willingness to travel to study sites (up to 20%)
Benefits
- Health insurance
- Prevention and wellness programs
- At least 14 weeks’ gender-neutral parental leave
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