Human Factors Engineer (1145622)

Location: Milford, OH • Onsite (no remote) • Relocation available for the right candidate

About the role

The Judge Group is seeking a Human Factors / Usability Engineer to lead Human Factors Engineering (HFE) and usability engineering activities for medical device development. You will serve as the bridge between patients, nurses, healthcare providers, engineering, quality, regulatory affairs, and pharmaceutical customers, influencing product design decisions and acting as a key contact with pharmaceutical partners.

Responsibilities

• Conduct and oversee usability studies, user interviews, task analyses, and validation testing.
• Translate user feedback into actionable design requirements for engineering teams.
• Manage risk assessments related to device use and ensure compliance with FDA and international standards (ISO, FDA, MDD, IEC 62366-1).
• Develop and maintain Instructions for Use (IFU) documentation and regulatory submissions.
• Interface with customers, contractors, and consultants.

Requirements

• BS in Human Factors, Engineering, or Industrial Design.
• 6+ years of experience in medical devices or pharmaceuticals.
• 3+ years of experience in product or process development.
• Experience with usability studies and analyzing associated data.
• ISO, FDA, MDD, and IEC 62366-1 experience.
• Must be a US Citizen or Green Card Holder.

Preferred Qualifications

• MBA.

Pay

$120,000 – $150,000 USD annually (compensation range: $160,000 – $175,000 for the right candidate).