Senior Human Factors Engineer - Medical Devices

INFOSYS NOVA HOLDINGS LLC; Seattle (WA); On-site; USD 98,000 - 140,000; Full time

Job summary

INFOSYS NOVA HOLDINGS LLC is seeking a Human Factors Engineer in Seattle, WA, onsite, to support the development of medical devices and combination products. You will ensure user needs, safety, and usability are integrated throughout the product lifecycle and collaborate with engineering, marketing, medical, and regulatory teams.

The role focuses on user research, usability studies, use-related risk assessments, and FDA regulatory submissions, with opportunities to publish and educate on HF

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.

Responsibilities

• Provide expert HF engineering guidance based on usability activity results.
• Lead planning and execution of user research studies and usability tests.
• Perform use-related risk assessments and document HF evaluations.
• Draft technical documents for usability files and regulatory submissions.

Skills

Human Factors Engineering

User research

Usability testing

Regulatory submissions

Job description

INFOSYS NOVA HOLDINGS LLC is seeking a Human Factors Engineer in Seattle, WA, onsite, to support the development of medical devices and combination products. You will ensure user needs, safety, and usability are integrated throughout the product lifecycle and collaborate with engineering, marketing, medical, and regulatory teams.

The role focuses on user research, usability studies, use-related risk assessments, and FDA regulatory submissions, with opportunities to publish and educate on HF