Senior Human Factors Engineer - Onsite with Relocation

The Judge Group; Milford (OH); On-site; USD 120,000 - 175,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

The Judge Group is seeking a Senior Human Factors / Usability Engineer in the Milford, OH area with strong experience leading 6+ years of experience in medical devices or pharmaceuticals. The role requires onsite work and relocation is available for the right candidate.

Responsibilities include leading HFE activities, conducting usability studies, turning feedback into design requirements, and ensuring FDA/IEC compliance for regulatory submissions.

Qualifications

• BS in Human Factors, Engineering or Industrial Design.
• 6+ years in medical devices or pharmaceuticals.
• 3+ years product or process development.
• Experience with usability studies and data analysis.
• ISO, FDA, MDD experience; FDA human factors and IEC 62366-1.

Responsibilities

• Lead Human Factors Engineering (HFE) and usability engineering activities for medical device development.
• Conduct usability studies, user interviews, task analyses, and validation testing.
• Turn user feedback into design requirements for engineering teams.
• Manage risk assessments related to device use and ensure regulatory compliance.
• Develop and maintain Instructions for Use (IFU) documentation and regulatory submissions.
• Serve as liaison between patients, healthcare providers, engineering, quality, regulatory affairs and pharmaceutical customers.

Skills

Lead HFE

Usability studies

FDA experience

IEC 62366-1

Regulatory submissions

Education

BS in Human Factors

Engineering degree

Industrial Design

Job description

The Judge Group is seeking a Senior Human Factors / Usability Engineer in the Milford, OH area with strong experience leading 6+ years of experience in medical devices or pharmaceuticals. The role requires onsite work and relocation is available for the right candidate.

Responsibilities include leading HFE activities, conducting usability studies, turning feedback into design requirements, and ensuring FDA/IEC compliance for regulatory submissions.