Lead Human Factors Engineer – Medical Devices (Onsite)

The Judge Group, INC.; Milford (OH); On-site; USD 160,000 - 175,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

The Judge Group is seeking a Senior Human Factors/Usability Engineer for the Milford, OH area. The role requires strong leadership in human factors within medical devices or pharmaceuticals, with 6+ years of relevant experience and ISO/FDA/MDD expertise. Relocation is available for the right candidate.

Onsite work only, with a compensation range of $160,000 to $175,000. A BS in Human Factors, Engineering, or Industrial Design is mandatory, and MBA is a plus.

Qualifications

• BS in Human Factors, Engineering, or Industrial Design is required.
• 6+ years of experience in medical devices or pharmaceuticals.
• Experience with ISO, FDA, and MDD.
• FDA human factors and IEC 62366-1 experience preferred.

Responsibilities

• Lead Human Factors Engineering (HFE) and usability engineering activities for medical device development.
• Conduct usability studies, user interviews, task analyses, and validation testing.
• Translate 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) documents and regulatory submissions.
• Serve as liaison with patients, nurses, healthcare providers, engineering, quality, regulatory, and pharmaceutical partners.

Education

BS in Human Factors / Engineering / Industrial Design

Tools

FDA/IEC 62366-1 experience

Job description

The Judge Group is seeking a Senior Human Factors/Usability Engineer for the Milford, OH area. The role requires strong leadership in human factors within medical devices or pharmaceuticals, with 6+ years of relevant experience and ISO/FDA/MDD expertise. Relocation is available for the right candidate.

Onsite work only, with a compensation range of $160,000 to $175,000. A BS in Human Factors, Engineering, or Industrial Design is mandatory, and MBA is a plus.