Reporting to the Director/Associate Director of Device Development and Technology,Device Manager, Human Factors is the technical expert in the field of human factors as it relates to combination products, drug delivery devices and healthcare apps. This position will manage all aspects of human factors in order to develop safe and effective systems for use by patients or professionals. Works with teams to design products that meet the needs of the intended users. Create task analysis, risk assessments and integrate current regulatory thinking into this work. Designs and executes studies to assess optimal use scenarios, then assesses results to further optimize the system. Manages all aspects of studies, including validation and report writing. Work with multi-disciplinary teams to design and refine instructions for use for devices and apps or software. This position will involve management of outside resources as well as guidance and leadership of project teams in a matrix organization. Additional responsibilities include facilitation of risk assessments. This position will frequently require management of outside resources as well as assigned and/or unassigned leadership of project teams in a matrix organization.
- Ensure the proper conduct of studies with regulations and SOPs.
- Develop and maintain departmental knowledge, experience, and expertise on human factors as it relates to devices, apps and combination products.
- Assure adherence to latest worldwide regulatory rules and guidance concerning devices and work to develop device risk mitigation.
- Create, maintain and update device related documents required for regulatory filings and compliance
- Facilitate/Oversee studies as required.
- Bachelor’s degree in a related discipline (Human Factors, Industrial Design, Psychology, Biomedical Engineering, etc.)
- Deep understanding with the process and development of instructions for use, healthcare apps, and devices.
- 10 -15 years’ experience in Pharmaceuticals, Medical Devices, Research, Biotechnology or other related industries or fields.
- Demonstrated leadership skills especially the management of high-visibility project teams
- Demonstrated knowledge of apps, medical devices, or parenteral delivery devices (syringes, self/ or auto-injectors), etc.
- Understanding of device verification and validation techniques including formative and validation studies and regulatory requirements as they pertain to apps and devices.
- Competency in use of business and project management computer software (such as MSProject and MSOffice).