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 helps clients develop electronic medical devices and other high-tech systems by integrating with their R&D teams to cover the full product lifecycle, from planning and design to prototyping, verification, and transfer to production while complying with ISO 13485 and FDA 21 CFR 820. It provides end-to-end services including hardware, embedded software, and mechanical engineering with in-house labs and short-run manufacturing capabilities. Unlike others, it embeds its teams within client organizations and offers white-label design and manufacturing, delivering hands-on engineering and seamless production transfer. Its goal is to help customers bring safe, compliant, market-ready devices to market efficiently as their R&D needs grow.

Company Size

51-200

Company Stage

N/A

Total Funding

N/A

Headquarters

Prairie Village, Kansas

Founded

2007

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Simplify's Take

What believers are saying

April 2025 expansion tripled capacity, supporting more concurrent client programs.
August 2026 website updates show nearly 100 employees and continued hiring momentum.
June-August 2026 PFA articles position Engenious for pulsed-field ablation development work.

What critics are saying

Project-based consulting revenue depends on client R&D budgets and program cancellations within quarters.
2026 PFA-generator content signals broader scope, stretching teams across high-voltage and medical-device work.
The 2022 UV-LED patent settlement leaves lingering legal and reputational overhang.

What makes Engenious Design unique

Nearly 100 engineers inside a 56,000-square-foot Prairie Village design center.
In-house electronics, test, prototype, and short-run production compress medical-device iteration cycles.
ISO 13485 and 21CFR820 discipline attracts Class II, III, and PMA programs.

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Benefits

Unlimited Paid Time Off

Parental Leave

Flexible Work Hours

Health Insurance

Life Insurance

Dental Insurance

Vision Insurance

401(k) Retirement Plan

401(k) Company Match

Health Savings Account/Flexible Spending Account

Performance Bonus

Growth & Insights

Headcount

Engenious Design

Senior Human Factors Engineer

About the job