Human Factor Staff Engineer (MedTech)

TL;DR

Human Factor Staff Engineer (MedTech): Leading usability engineering across the product lifecycle for cardiovascular surgical devices and systems with an accent on ensuring products are safe, effective, and intuitive in complex clinical environments. Focus on use-related risk analysis, labeling/UI development, clinical simulation, and summative/validation studies.

Location: Wayne, NJ, US

Salary: $125-150K with 10% STIP

Company

hirify.global provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows.

What you will do

• Lead contextual inquiry, ethnography, and workflow mapping in cardiovascular surgery settings.
• Translate insights into user needs, intended use, and use specifications; define user personas and critical tasks.
• Plan and execute formative evaluations, synthesize findings, and iterate designs.
• Lead use-related risk analysis and ensure alignment with Design Controls.
• Plan and execute human factors validation studies per IEC 62366-1 and FDA HF guidance.
• Partner with Clinical, Marketing, and Design to prioritize unmet needs and stakeholder feedback.

Requirements

• Bachelor’s degree in Human Factors Engineering, Biomedical Engineering, Cognitive/Experimental Psychology, HCI/UX, Industrial Engineering, or related field required. Master’s degree preferred.
• 8 years of experience in Human Factors/Usability Engineering for complex systems, preferably Class II/III medical devices.
• Demonstrated experience with OR or interventional workflows strongly preferred (cardiovascular surgery, structural heart, electrophysiology, perfusion, imaging, pumps/dispensers, or energy devices).
• Track record delivering both formative and summative studies and authoring HFE documentation for regulatory submissions.
• Deep knowledge of IEC 62366-1, FDA HF Guidance, AAMI HE75, AAMI TIR50/51, IEC 60601-1-6, ISO 14971, ISO 13485, and 21 CFR 820.30.
• Proficiency in use-related risk analysis, task analysis, critical task identification, and linkage to risk controls across UI, labeling, training, and design features.

Culture & Benefits

• Health, Dental, and Vision insurance benefits.
• 401k plan with company match.
• Paid Time Off.
• Wellness initiative & Health Assistance Resources.
• Life Insurance.
• Short and Long Term Disability Benefits.