Senior Human Factors Engineer

The Role

The Senior Human Factor Engineer will have roughly 5-10 years of experience in product development of medical products. This role will play a key part in the design, development, use testing, documentation, and launch of Goddard’s clients’ products. You will take part in human factors & usability engineering activities for new product development programs and contribute to usability improvements for current products, collaborating with a diverse team of product development specialists and working in a dynamic, fast-paced environment.

Responsibilities

• Serve as a patient / customer advocate in helping Goddard realize its vision for delivering game-changing products that are safe & effective, easy to use, not prone to use error, and provide user satisfaction; ultimately supporting Goddard’s goal of extremely low burden of care
• Support product management and product engineering personnel in establishing ergonomic, human factors (HF), and usability-related requirements for new products and product line extensions
• Represent the human factors/usability engineering function on core teams for small to large sized projects
• Implement a variety of HFE research methods, such as task analysis, PCA, time/motion study, user preference studies, ethnographic research, heuristic analysis, root cause analysis, post-market data analysis and usability testing
• Analyze quantitative and qualitative data to inform design decisions and risk analyses and contribute to user interface designs by providing heuristic design guidance, ideas, and feedback to project teams
• Create and leverage URRAs, uFMEAs and/or UEAs to inform design; collaborating with systems engineering in identifying intended users and use environments, as well as potential use-related hazards; determine product use cases and identify critical user tasks, errors and design mitigations
• Support documentation review and development, including but not limited to risk analyses, user/environment profiles, task analyses, use specifications and human factors engineering reports to support regulatory filings
• Have a working knowledge of the implementation of all relevant HF & usability-related standards and guidance documents (ANSI/AAMI/ISO 14971, AAMI/ANSI HE75, ANSI/AAMI/IEC 62366, IEC 60601, FDA, etc.)
• Travel as-needed (valid driver’s license and vehicle required)

Qualifications

• Bachelor’s degree and 5+ years of human factors/usability engineering experience. Prior consulting experience preferred
• Experience working in the medical device industry required and adhering to the latest regulatory standards and industry best practices
• Strong communicator, creative thinker and team player with the ability to collaborate with both internal and external parties
• Flexible to take on additional responsibilities to support an agile and growing team
• Advocate for the patient/customer, and passionate about the value of human factors/usability in the medical device industry
• Able to embrace uncertainty, energized by tackling challenges head-on, and enjoy having the opportunity to learn something new every day (be it a new product, tool, technology, methodology or standards)