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 #jdp #J-18808-Ljbffr
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