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.The experience expected from applicants, as well as additional skills and qualifications needed for this job are listed below.COMPENSATION: 160k to 175kWORKSITE: Onsite (NO REMOTE)RELOCATION: Available for the right candidateMUST HAVE: BS, Human Factors, Engineering, Industrial DesignMUST HAVE: 6+ years of experience in medical devices or pharmaceuticalsMUST HAVE: ISO, FDA, MDD experienceMUST HAVE: FDA human factors and IEC 62366-1 experienceLIKE TO HAVE: MBAMUST BE: A US Citizen or a Green Card HolderEXPERIENCE:Lead Human Factors Engineering (HFE) and usability engineering activities for medical device developmentConducting 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. xhyhwjd Becomes the bridge between patients, nurses, healthcare providers, Engineering, Quality, Regulatory Affairs and pharmaceutical customersThe position also serves as a key contact with pharmaceutical partners and influences product design decisions.REQUIRED:BS, Human Factors, Engineering, Industrial Design6+ years of experience in medical devices or pharmaceuticals3+ year of experience in product or process developmentExperience with usability studies and analyzing associated dataExperience interfacing with customers, contractors and consultantsISO, FDA, MDD experienceFDA human factors and IEC 62366-1 experience
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