Engenious Design

Medical device design and engineering partner

Senior Human Factors Engineer

UX ResearchConfirmed live in the last 24 hours

Full-timePrairie Village, KS, USANo salary listed

About the Job

Requirements

A Bachelor of Science or Bachelor of Arts degree in Human Factors Engineering, Usability Engineering, Human Computer Interaction, Biomedical Engineering, or an equivalent field.
At least 5 years of experience planning and executing formative and summative studies.
Expertise in proctoring hands-on usability studies.
Ability to translate research, study results, and insights into user needs or design inputs.
Familiarity with Food and Drug Administration, International Organization for Standardization, International Electrotechnical Commission, American National Standards Institute, Association for the Advancement of Medical Instrumentation, and other relevant usability regulations and standards.
Effective communication and collaboration with engineers, designers, and management stakeholders.
Ability to meet client and clinical-partner immunization and health-screening requirements, which may include proof of immunity or vaccination for measles, mumps, and rubella; varicella; hepatitis B; tetanus, diphtheria, and pertussis; annual influenza; COVID-19; and tuberculosis screening.
Authorization to work in the United States without requiring visa sponsorship.

Responsibilities

Plan and conduct user research to uncover 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 documentation for regulatory submissions.
Collaborate with designers, systems engineers, mechanical engineers, electrical engineers, software engineers, and product managers to define and implement user-centered design solutions.
Observe users interacting with designed systems, conduct interviews, and partner with clinicians to understand their viewpoints.

Desired Qualifications

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

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.

Key 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.
Enjoy a variety of projects and people while doing meaningful work.
See your work help real people. 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.

Position Details:
This is a full-time, permanent position. This position works from our Kansas City based office during core business hours.

While we recognize that top talent comes from all over the world, we are a small team and are not able to offer visa sponsorship at this time. Candidates must be authorized to work in the United States without requiring visa sponsorship.

Because this role involves work in credentialed environments, 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.

Required Qualifications:

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.

Desired Qualifications:

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

About the Company

Engenious Design

Medical device design and engineering partner

Engenious Design provides product design and engineering services for electronic medical devices and other high-technology systems. It works by embedding its teams with client R&D departments to cover planning, design, prototyping, verification, validation, and production transfer under ISO 13485 / 21 CFR 820, for devices including FDA Class II, III, and PMAs. The company combines in-house electronics labs, test labs, prototyping, and short-run manufacturing to deliver end‑to‑end hardware, embedded software, and mechanical engineering, including white-label design services. Its differentiation comes from acting as collaborative design partners within client teams and offering integrated transfer-to-production capabilities, with accomplishments across medical devices and complex systems like Blue Origin’s battery projects. Engenious Design aims to help clients bring safe, compliant, market-ready products to life efficiently while scaling R&D as needed.

Company size: 51-200
Company stage: Not listed
Total funding: Not listed
Headquarters: Prairie Village, KS
Founded: 2007

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