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

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