Senior Human Factors Engineer

Engenious DesignPrairie Village, KS
Onsite

About The Position

The Senior Human Factors Engineer is a key member of the Engenious Design team. The Human Factors expert is an insightful and empathetic observer of users and their needs, translating these insights into actionable inputs for engineers, designers, and product managers. In this role, you will have the opportunity to directly impact the safety, usability, and effectiveness of life-changing devices by ensuring they are built around the real needs of clinicians, patients, and caregivers. You will join a collaborative, cross-functional team working on high-impact, high-tech systems that improve healthcare outcomes. This key team member is not afraid to go see how users interact with the systems we are designing, observing clinical practice in person, conducting interviews, and generally partnering with clinicians to understand their viewpoints. They are equally comfortable talking to clients, project managers, and engineering partners. We create medical devices that save and improve lives such as designing and building life-sustaining medical devices and other advanced electromechanical technology. Build a portfolio to be proud of with opportunities to work on medical and consumer products.

Requirements

  • BS/BA Degree in Human Factors Engineering (HFE), Usability Engineering, Human Computer Interaction (HCI), Biomedical Engineering, or equivalent.
  • 5+ years of proven experience in the planning and execution of formative and summative studies.
  • Expert in proctoring hands-on usability studies.
  • Demonstrated ability to translate research, study results, and insights into user needs and/or design inputs.
  • Familiar with FDA, ISO, IEC, ANSI/AAMI, and other relevant usability regulations and standards.
  • Effective communication skills and capacity to collaborate with engineers, designers, and management stakeholders.
  • Candidates must be authorized to work in the United States without requiring visa sponsorship.
  • The employee must meet all immunization and health-screening requirements established by our clients, and their clinical partners. This may include, but is not limited to, proof of immunity or vaccination for MMR, Varicella, Hepatitis B, Tdap, annual influenza, and COVID-19 (varies by site), as well as a tuberculosis screening.

Nice To Haves

  • Familiar with risk analysis documentation.
  • Experience in healthcare or other regulated industries.
  • Experience with Class II or Class III medical devices.

Responsibilities

  • Plan and conduct user research.
  • Gather insights to uncover user needs, workflows, and pain points.
  • Create protocol plans and proctor usability studies (formative and summative).
  • Be a subject matter expert in relevant standards documentation including but not limited to IEC 60601, IEC 62366, ISO 14971, and AAMI/ANSI HE75.
  • Prepare thorough documentation for regulatory submissions.
  • Collaborate with designers, engineers (systems, mechanical, electrical, software), and product managers to define and implement user-centered design solutions.
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