My client is taking immunotherapy to the next level in the fight against cancer and infectious diseases. The company is advancing a growing clinical and preclinical stage product pipeline. Partners and collaborators include MedImmune, University of Pennsylvania, DARPA, GeneOne Life Science, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and University of Manitoba.
Job summary
Lead Human Factors & Usability Engineering activities for new product development programs and drive usability improvements for current products.
• Support Product Management and Product Engineering personnel in establishing human factors (HF) and usability-related requirements for new products and product line extensions
• Conduct internal and external Usability testing throughout the product development process, from formative testing of early prototypes through summative testing of final designs.
• Oversee outside consultants to effectively and efficiently support product development efforts within the company.
• Develop and maintain the uFMEA for new and existing products.
• Develop and maintain product user manuals
• Create product concept models such as story boards, mockups, workflow diagrams, use cases, etc.
• Work with external test houses on IEC 60601-1-6
Minimum requirements
• Extensive knowledge and understanding of the Human Factors Usability Engineering process for medical devices
• human factors education and experience with various human factors research methods
• Understanding of Risk Management Process based on IEC 14971
• In-depth knowledge of IEC 62366 and AAMI HE75
• Practical knowledge of FDA QSR 820 and ISO13485 require
• Minimum 7 years industry experience working in human factors / usability with Medical Devices