Senior Human Factors Engineer

Engenious Design • Prairie Village, KS

76d • Onsite

About The Position

The Senior Human Factors Engineer is a key member of the Engenious Design team, bringing an insightful and empathetic understanding of users and their needs to inform engineers, designers, and product managers. The role helps ensure that medical devices are designed around the real needs of clinicians, patients, and caregivers, directly contributing to their safety, usability, and effectiveness. The position involves observing clinical practice, conducting interviews, and partnering with clinicians, as well as working with clients, project managers, and engineering partners. The successful candidate will contribute to a collaborative, cross-functional team developing high-impact healthcare systems and medical and consumer products. This is a full-time, permanent position based in the Kansas City office during core business hours. Visa sponsorship is not available; candidates must be authorized to work in the United States without requiring sponsorship. Employees must meet client and clinical-partner immunization and health-screening requirements, which may include proof of immunity or vaccination for MMR, Varicella, Hepatitis B, Tdap, annual influenza, and COVID-19 (requirements vary by site), as well as tuberculosis screening.

Requirements

• Bachelor's degree in Human Factors Engineering (HFE), Usability Engineering, Human Computer Interaction (HCI), Biomedical Engineering, or equivalent.
• At least 5 years of proven experience planning and executing formative and summative studies.
• Expertise in proctoring hands-on usability studies.
• Demonstrated ability to translate research, study results, and insights into user needs and/or design inputs.
• Familiarity with FDA, ISO, IEC, ANSI/AAMI, and other relevant usability regulations and standards.
• Effective communication skills and ability to collaborate with engineers, designers, and management stakeholders.
• Authorization to work in the United States without visa sponsorship.
• Ability to meet client and clinical-partner immunization and health-screening requirements, including applicable vaccinations or proof of immunity and tuberculosis screening.

Nice To Haves

• Familiarity 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 to identify user needs, workflows, and pain points.
• Create protocol plans and proctor formative and summative usability studies.
• Serve as a subject matter expert on relevant standards documentation, including IEC 60601, IEC 62366, ISO 14971, and AAMI/ANSI HE75.
• Prepare thorough documentation for regulatory submissions.
• Collaborate with designers, systems, mechanical, electrical, and software engineers, and product managers to define and implement user-centered design solutions.
• Observe clinical practice in person, conduct interviews, and partner with clinicians to understand their viewpoints.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior