Human Factors Engineer

Judge Direct Placement; 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 in the Milford, OH area with 6+ years of experience in medical devices or pharmaceuticals. This on-site role requires ISO, FDA, MDD experience and FDA human factors IEC 62366-1 knowledge.

Responsibilities include leading HFE activities, usability studies, turning user feedback into design requirements, and managing regulatory submissions. Relocation is available for the right candidate.

Qualifications

• 6+ years of experience in medical devices or pharmaceuticals.
• 3+ years of experience in product or process development.
• Experience with usability studies and analyzing data.
• ISO, FDA, MDD experience.
• FDA human factors and IEC 62366-1 experience.
• MBA preferred

Responsibilities

• Lead Human Factors Engineering (HFE) and usability 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 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 partners.

Skills

Human factors

Usability testing

User research

Risk management

Regulatory liaison

Education

MBA

Job description

The Judge Group is seeking a Human Factors / Usability Engineer in the Milford, OH area with strong experience leading 6+ years of experience in medical devices or pharmaceuticals.

COMPENSATION: 160k to 175k

WORKSITE: Onsite (NO REMOTE)

RELOCATION: Available for the right candidate

MUST HAVE: 6+ years of experience in medical devices or pharmaceuticals

MUST HAVE: ISO, FDA, MDD experience

MUST HAVE: FDA human factors and IEC 62366-1 experience

LIKE TO HAVE: MBA

MUST BE: A US Citizen or a Green Card Holder

EXPERIENCE:

• Lead Human Factors Engineering (HFE) and usability engineering activities for medical device development
• Conducting and overseeing usability studies, user interviews, task analyses, and validation testing.
• Turning user feedback into design requirements that engineering teams can implement.
• Managing risk assessments related to device use and ensuring compliance with FDA and international standards.
• Developing and maintaining Instructions for Use (IFU) documentation and regulatory submissions.
• Becomes the bridge between patients, nurses, healthcare providers, Engineering, Quality, Regulatory Affairs and pharmaceutical customers
• The position also serves as a key contact with pharmaceutical partners and influences product design decisions.

REQUIRED:

• 6+ years of experience in medical devices or pharmaceuticals
• 3+ year of experience in product or process development
• Experience with usability studies and analyzing associated data
• Experience interfacing with customers, contractors and consultants
• ISO, FDA, MDD experience
• FDA human factors and IEC 62366-1 experience