The Human Factors Engineer will be a critical role in ensuring the success of our vision to improve patient outcomes. Under the direction of the Head of Product Management, Digital Health Solutions, this position will provide human factors engineering expertise to project teams developing software-as-a-medical device (SaMD) products, in partnership with the Roche Pharma PHC organization. They will be responsible for conducting user research and usability testing of SaMD products to ensure the products are safe, easy to use, and easy to learn by analyzing risks, and developing and executing Human Factors testing. They will work closely with Product Managers, Product Owners, UX researchers, engineers, and the quality and regulatory teams to deliver on the product’s vision.
● Collaborates with multi-functional teams including Product Management, Engineering, Regulatory, Clinical, and Quality to inform and guide development of innovative products and ensure that those products are safe and easy to use.
● Develop and execute HFE plans for best in class usability and requirements of medical device regulatory agencies around the world (FDA HFE Guideline, IEC 62366, IEC 62304 etc).
● Provide input to support product compliance to all applicable standards including IEC, ISO, ANSI, and FDA.
● As part of product development, conducts human factors engineering activities within device development programs including ethnographic research, requirements definition research, use-related risk analysis, formative usability assessments, and final summative design validation studies.
● Develops instructions for use and training materials for commercial purposes.
● Collect and synthesize detailed information about how users interact with the products through various techniques including interviews, simulations, direct observation, task analysis, and persona development.
● Present results of field observations, research, and usability testing to the product development organization and contribute to user interface designs by providing guidance, ideas, and feedback to UI Designers and product managers.
● Analyze complaints from on-market products for usability-related issues.
● Work with cross functional teams to create and maintain usability risk analyses and user interface requirements, and maintain traces between use risks, mitigations, and validation test cases.
● Keep abreast of regulations and best practices for medical device human factors (e.g. IEC 62366, AAMI HE75, FDA Applying Human Factors and Usability Engineering to Medical Devices)
Who you are:
● Bachelor’s or Master’s degree in Human Factors Engineering, Cognitive Psychology, Computer Science with human-computer interface (HCI) emphasis, Human Centered Design, or related discipline.
● 5+ years of relevant experience in the pharmaceutical, biotech or medical device industry, or an advanced degree in a relevant discipline;
● Ability to write formative and summative usability study protocols and reports, and author human factors summary reports consistent with health authority expectations.
● Experience in Product Delivery following a Quality Management Framework in the Healthcare and regulatory space (SaMD product experience preferred)
● Experience working within the global medical device regulatory frameworks such as IVDR, MDR, SaMD, etc.
● Ability to work cross-functionally on risk management activities.
● Ability to design instructions for use (IFU) documents and training materials for medical devices/combination products and conducting usability testing of them.
● Demonstrated ability to analyze data, including knowledge and proficiency with basic statistics.
● Proven ability to clearly communicate how study results can be implemented into design.
● Working knowledge of relevant human factors, design controls, and risk management regulations, standards, and guidances for medical devices and combination products preferred.
● Ability to communicate effectively in writing, verbally, and as a presenter.
● Demonstrated time management, decision making, presentation, and organization skills.
● Strong interpersonal skills and the ability to collaborate actively and proactively with others in a cross-functional team.
● High level of initiative and ability.
● Personally motivated, creative thinker and accountable team player. Demonstrated ability to respectfully provide and receive feedback
● Successful prior experience working in medical device, health sciences, high-tech, or cloud technologies industry preferred.
● Knowledge in SaaS and mobile apps strongly preferred.