Human Factors Engineer - Medical/Pharma/Biotechnology - FDA/Drug Administration
Senior Human Factors Engineer
As a member of the User Experience Design team, the Human Factors Engineering Strategist (HFE) is an expert leader in understanding customers' emotions and behaviours and at uncovering meaningful; and surprising insights to drive design decisions. This HFE uses customer insights to inspire teams to deliver experiences that solve customer problems and transform their work life.
The HFE is an expert at methodologically sound and innovative customer research and in discovering new business opportunities for future growth. HFEs are expert at running research studies, analysing the data, and using storytelling, data, and visualizations to lead project teams in translating findings into successful product designs. The HFE conducts task flow analysis, usability testing, and use error analysis in an FDA-regulated industry for current and next-generation hardware products and software. The individual in this position will work in a highly collaborative, cross-functional team to deliver products with best-in class user experience.
- Apply creative problem-solving strategies and techniques to get tactical, innovative, and disruptive ideas launched
- Seek to create the best possible product or service for our customers by finding the sweet spot between customers' needs, business constraints, and technical capabilities
- Communicate passion and empathy for the customer in a way that is contagious and inspires teams to keep iterating until the best-possible solution (within given constraints) is found
- Apply FDA Human Factors Engineering processes to determine customer needs and requirements for medical devices and software
- Deliver task analyses, wireframes, user error analysis, and develop success criteria, analyze results, and provide recommendations to product teams and cross-functional stakeholders
- Collaborate closely with interface designers, engineers, and the marketing team and business leaders to define detailed designs that meet customer needs and to motivate teams to seek, utilize, and apply customer insights throughout the product and service life cycle
- Plan and execute methodologically sound usability testing, data analysis, results documentation and presentations following BD processes and the guidelines of the FDA (IEC 62366, AAMI HE75)
- Facilitate and complete use error analyses, user interface specifications, and various FDA-specified documents that are part of the Usability Engineering File
- Able to understand business goals and link them to design directions and product architecture and advocate for short-term solutions that support long-term product visions and business strategies.
- Lead brainstorming and ideating sessions, report outs to stakeholders, and innovation research
- Teach human factors processes and understanding of our customers to cross-functional project teams as well as leaders and less-senior human factors engineers
- Develop and evangelize human factors based product growth strategies and long-term roadmaps
- Write and deliver influential speeches and articles within BD and externally
- BS in Engineering, Human Factors Engineering/Ergonomics, Usability Engineering, Cognitive/Experimental Psychology, Industrial Design, Engineering Psychology or equivalent degree
- Minimum of 10 years of professional UX/HFE experience in developing software and/or hardware
- Demonstrated track record of success analzying user needs via contextual research, usability testing, and other validation methods
- Experience mentoring human factors engineers and cross-functional teams on HF processes
- Experience in healthcare and FDA experience in software design and development
- Excellent collaboration, communication, leadership, influencing, and presentation skills