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The Judge Group, INC.

Human Factors Engineer

milford, OH

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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

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Worksite address

milford, OH, 45150, US

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