• Apply Human Factors Engineering (HFE) techniques and principles at all phases of product/technology development.
• Develop user study criteria and detailed methodology for hardware and software user interface testing for several projects. Develop study methodology, conduct user-centered research, and evaluation for design concept models on a diverse user population and analyze data utilizing study data, anthropometric databases, and scientific publications.
• Conduct statistical and qualitative analysis of data and provide clear and concise feedback to cross-functional teams.
• Relevant experience in regulated medical device usability evaluations and documentation.
• Knowledge of regulations and best practices for medical device human factors a plus (e.g. IEC 62366, AAMI HE75, FDA Applying Human Factors and Usability Engineering to Medical Devices).
• Masters or Bachelors degree in biosciences, engineering, respiratory therapist, nursing or equivalent discipline
• 3+ years of experience in biotechnology, pharmaceutical or medical device industries
• ICU, hospital or medical devices experience
• Good knowledge of IEC 62366
• Work experience in Human Factors Engineering/Human Factors Validation
• Proven experience throughout the product life of a combined hardware and software medical device
• Solid clinical background with understanding of human physiology, the clinical workflow and applied technologies in hospital critical care
• Ability to travel 15-30% of the time domestically and/or abroad
• 3+ years of experience in preclinical setting or regulated medical device development (executing preclinical studies, first in human studies and IDE studies experience are a plus)
• Experience with and/or knowledge of FDA submission and approval processes
Inquiries and resumes to: Kathy Provost at firstname.lastname@example.org OR 978/952-6425
For more information, please visit https://www.agilesearchinc.com/