Human Factors Engineer

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 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: BS, Human Factors, Engineering, Industrial Design

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:

• BS, Human Factors, Engineering, Industrial Design
• 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

#jdp