Human Factors Engineer - Medical Devices & FDA Submissions

Kaleidoscope; Seattle (WA); On-site; USD 98,000 - 140,000; Full time

Job summary

Kaleidoscope is seeking a Human Factors Engineer in Seattle to guide usability and safety across medical device development. You will partner with engineering, marketing, medical, and regulatory teams to plan, execute, and document human factors activities that support design decisions and regulatory submissions.

Responsibilities include leading user research, usability studies, use-related risk analysis, HF Validation, and drafting use specifications.

Qualifications

• 5-8 years of experience with medical devices and FDA submissions.
• Experience in early-stage human factors research/activities in innovation/early phase projects.
• Planning and executing usability studies, and preparing FDA submission documents.
• Combination product or medical mobile app experience is a bonus but not necessary.

Responsibilities

• Provide expert HF guidance based on usability activity results and Human Factors Engineering principles.
• Provide use-related input into the creation of product and system requirements based on user needs and HF expertise.
• Plan and conduct Human Factors activities, including user research studies and usability studies.
• Lead the reporting and disposition of HF evaluation findings and risk analyses.
• Draft technical documents for usability files and regulatory submissions.

Skills

Human Factors Engineering

User research

Usability testing

Regulatory submissions

Job description

Kaleidoscope is seeking a Human Factors Engineer in Seattle to guide usability and safety across medical device development. You will partner with engineering, marketing, medical, and regulatory teams to plan, execute, and document human factors activities that support design decisions and regulatory submissions.

Responsibilities include leading user research, usability studies, use-related risk analysis, HF Validation, and drafting use specifications.