The Role
The Human Factors Engineer plans and conducts user research, creates usability study protocols, and collaborates with engineers and designers to enhance medical device usability. They aim to understand user needs and document regulatory submissions, ensuring compliance with relevant standards.
Summary Generated by Built In
The 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:
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:
Desired Qualifications:
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.
- 3+ 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.
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The Company
What We Do
Our engineering team is a booster rocket for accelerating medical device design; we help clients launch products with certainty. We fold into client development teams, working alongside as design partners. Our uniquely-integrated approach means lower-risk development and more transparency. Our team’s portfolio includes FDA Class II, III and PMA devices. We plan, specify, architect, design, prototype, verify, validate and transfer devices to production. Our focus is on electronic, mechanical and embedded software medical devices. Because of our medical device focus, we have an ISO:13485 / 21CFR820 - compliant quality system.
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