User-Centered Medical Device Usability Engineer

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

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.