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Engineering
Chemical / Process Engineer
Milford, OH
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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
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