The Human Factors position leads human factors (“usability engineering” in international standards) for the organization. The person in this role contributes to product design, product development and product quality across the development lifecycle by developing and driving Dexcom’s human factors/usability strategy. Early in development, the human factors contribution may gather and clarify requirements via usability testing of prototype designs. Dexcom will design future products using a participatory design approach, and findings from testing will be fed back to design teams to improve the products. The position provides product development teams with in-depth use analysis of designs in development.
Future projects, such as those related to receiver changes, applicator improvements, phone apps, and labeling will require extensive human factors engineering activities, including but not limited to clarification of user needs, development of use cases, human factors analysis, and usability testing across the development process. The primary responsibility is to ensure that validation studies are successful; supporting rapid global regulatory approvals.
As the leader for usability evaluation, the HF Manager ensures that products are not only easy to understand and use, but also that they are safe and effective with respect to usability per FDA guidance and international standards on usability and human factors. The position is responsible for leading development and execution of formative studies and collaborating on the strategy, and then leading the development and execution of the summative testing.
The human factors team is one of several cross-functional groups contributing to the design and optimization of Dexcom products and training materials. It is essential that this position collaborates closely with cross-functional leadership and groups.
Essential Duties and Responsibilities
- Incorporate human factors engineering into product development processes in accordance with regulatory requirements. Help develop and execute user-centered design processes. Perform (or lead and delegate) human factors analyses such as use FMEA, task analysis, and heuristic evaluation when they are required.
- Design and execute (or lead and delegate) formal and informal human factors formative testing to assess effectiveness of the device UI, labeling, and training and collaborate with cross-functional teams to improve usability and safety of products. Provide feedback to and collaborate with design teams.
- Lead the strategy and design of summative usability protocols and questions to be used for global product registrations. May lead the execution of these protocols or supervise external vendors or employees on the execution and analysis.
- Collaborates on the human factors reports that will be submitted for regulatory approval. Participate in discussions (both early and post-submission) with FDA human factors engineers.
- Develop and optimize procedures and processes with cross-functional teams to enhance efficiency of product design activities across the development cycle.
- Leads and manages the human factors team and ensures close collaboration and establishment of common goals with cross-functional partners.
- Prepares and revises budget.
- This position assumes and performs other duties as assigned.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Qualified candidates will have comprehensive knowledge of Human Factors and User Interface methodology in order to prototype, evaluate, and document hardware/software related interaction concepts.
- Experience in human factors evaluations used in the development of Medical Systems- in particular medical devices used by consumers. Experience with teams developing diabetes technologies such as pumps, blood glucose meters, pens, or continuous glucose monitors is highly desirable.
- Experience in developing research methodologies and performing evaluations of mobile devices and apps is highly desirable.
- Proven track record of developing and executing human factors studies and getting Human Factors validation studies accepted by the FDA and EU regulators.
- Experience in all phases of research including early product concept design and throughout the product development phases.
- Familiarity with compliance with pertinent quality regulations (21 CFR Part 820.30), standards (e.g., IEC 62366, ISO 14971), and FDA guidance
- Strong record of cross-disciplinary leadership and collaboration with R&D, UI designers, industrial designers, clinical/medical affairs, statisticians, marketing, quality, regulatory and other functions.
- Requires strong communication and influence skills
- Experience in managing people and teams
- Ability to thrive in an organization that commonly changes priorities and in which speed to market is critical. Able to work on multiple projects.
- Must have a can do attitude and be “solution focused” with an ability to develop creative solutions to complex problems
Master's degree (M. A.) or equivalent in Human Factors Engineering, Human-Computer Interaction, Systems Engineering, Cognitive Psychology or related field ; and four to ten years related experience and/or training; or equivalent combination of education and experience.