Human Factors Engineer

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 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 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