Lead Human Factors Engineer (MedTech)

TL;DR

Lead Human Factors Engineer (MedTech): Leading usability engineering across the product lifecycle for cardiovascular surgical devices with an accent on front-end innovation and back-end validation. Focus on conducting ethnographic research, managing use-related risks, and executing summative validation studies to meet FDA and global regulatory requirements.

Location: Onsite in Wayne, NJ, US

Salary: $150,000 – $170,000

Company

Global medical technology company providing life-saving products and solutions for intensive care, cardiovascular procedures, and operating rooms.

What you will do

• Lead contextual inquiry, ethnography, and workflow mapping in cardiovascular surgery and interventional settings.
• Translate user insights into personas, critical tasks, and UI specifications to drive concept ideation.
• Create wireframes and develop low- to high-fidelity prototypes for software and hardware.
• Lead use-related risk analysis (U-FMEA) and ensure traceability between user needs, risks, and design inputs.
• Plan and execute summative validation studies according to IEC 62366-1 and FDA guidelines.
• Author HFE deliverables for regulatory submissions, including 510(k), PMA, and Technical Files.

Requirements

• Bachelor’s degree in Human Factors Engineering, Biomedical Engineering, Cognitive Psychology, or HCI/UX.
• 10+ years of experience in Human Factors leadership/Usability Engineering for Class II/III medical devices.
• Proven track record of delivering formative and summative studies for regulatory submissions.
• Deep expertise in IEC 62366-1, FDA HF Guidance, ISO 14971, and 21 CFR 820.30.
• Must be based in or able to work onsite in Wayne, NJ.

Nice to have

• Master’s degree in a related field.
• Professional HF/UX certification (CHFP, CUXP).
• Experience with OR or interventional workflows (cardiovascular surgery, electrophysiology, etc.).
• Proficiency with statistical software such as JMP or Minitab.

Culture & Benefits

• Comprehensive Health, Dental, and Vision insurance.
• 401k plan with company match.
• Paid Time Off, Parental, and Caregiver Leave.
• Tuition Reimbursement and Wellness initiative resources.
• Commuter benefits and Life/Disability insurance.