Human Factors Engineer at Engenious Design Prairie Village, KS

Comunidade Metodista; Prairie Village (KS); On-site; USD 90,000 - 130,000; Full time

Job summary

Engenious Design in Prairie Village, KS is seeking a Human Factors Engineer to join a cross-functional team. You will observe clinicians and patients, translate insights into actionable inputs for engineers, designers, and product managers, and help ensure safety and usability of medical devices.

This full-time role emphasizes planning and conducting formative and summative studies, proctoring usability sessions, and aligning with IEC 60601, ISO 14971, and related standards.

Qualifications

• BS/BA in HFE, usability, HCI, biomedical engineering, or equivalent.
• 3+ years planning/executing formative and summative studies.
• Expert in proctoring hands-on usability studies.
• Translate research results into user needs and design inputs.
• Familiar with FDA/ISO/IEC/ANSI/AAMI usability regulations and standards.
• Effective communication with engineers, designers and management.

Responsibilities

• Plan and conduct user research to uncover needs, workflows and pain points.
• Create protocol plans and proctor usability studies (formative and summative).
• Be a subject matter expert in IEC 60601, IEC 62366, ISO 14971, and AAMI/ANSI HE75.
• Prepare thorough documentation for regulatory submissions.
• Collaborate with designers, engineers, and product managers to define user-centered solutions.
• Enjoy a variety of projects and people while doing meaningful work.
• See your work help real people through medical devices and related tech.
• Build a portfolio of medical and consumer products.

Skills

User research

Usability studies

Regulatory familiarity

Cross-functional collaboration

Communication skills

Education

BS/BA in HFE or related

Job description

Human Factors Engineer job at Engenious Design. Prairie Village, KS.

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.

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.

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.