Sr. Human Factors Consultant

Job Title - Senior Human Factors Consultant

Department - Specialty Services-Core Human Factors

Reports To - Director, Human Factors Practice

Employment Status - Full-time/Exempt/Hybrid Position

Overview

The Senior Human Factors Consultant supports and/or conducts qualitative research studies for medical devices and combination products for clients across the healthcare space. In addition, this position is responsible for contributing to document-based deliverables, conducting interviews, analyzing data, and preparing documentation for regulatory submission.

This role will be hybrid, based out of our office in Chatsworth, CA combined with work-from-home.

Essential Job Functions

* Consult and guide clients on their human factors process with an understanding of relevant regulatory requirements.

* Contribute to the planning and development of document-based deliverables (e.g., use-related risk documentation, instructions for use, and usability study protocols).

* Conduct interviews with a wide range of representative users to collect qualitative data related to the use and perception of medical devices.

* Analyze both observational and qualitative interview data and develop reports presenting study findings to clients.

* Prepare documentation to support the human factors portion of an FDA submission (e.g., HFE/UE report) or other regulatory body submissions.

* Collaborate in a team setting with internal and external stakeholders.

Required Education and Certifications

* A postgraduate degree such as a Ph.D. or MS/MA is required. Preferred specialties include human factors engineering, cognitive science, psychology, biomedical engineering, public health, anthropology, neuroscience, behavioral sciences, nursing, or education.

Required Skills and Abilities

* Qualitative data analysis.

* Writing: Able to communicate effectively with technical writing to describe research plans and study results.

* Interviewing: Experience or interest in conducting one-on-one interviews with human subjects to collect real-time empirical and qualitative data.

* Spreadsheets: Experience or interest in working with MS Excel.

* Human Factors Engineering experience strongly preferred.

* Project management: Able to oversee and manage all aspects of a project lifecycle, including coordinating with vendors, client management/communication, and providing logistic/budgetary oversight.

* Mentorship: Able to mentor junior team members, assign work and lead workstreams.

* Capable of preparing effective proposals.

Physical Demands, Overtime, and Travel Requirements

Physical Demands - While performing this job, the employee is frequently required to stand, walk, sit, climb, bend, balance, stoop, kneel, crouch, talk, and hear. Clear vision and depth perception are also necessary. In addition, the employee may lift and/or move up to 50 pounds.

Overtime - This position is classified as salaried with exempt status. There will be periods where overtime and unconventional hours will be required, which the employee will need to comply with to meet the demands of the position.

Travel Requirements - This position requires offsite travel of approximately 25% annually.