Virtual Engineer
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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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