Staff Engineer - Human Factors - Indianola
L6
scorpion therapeuticsNew York, NYyesterday
Occupations
Human Factors Engineers and ErgonomistsBioengineers and Biomedical EngineersHealth and Safety Engineers, Except Mining Safety Engineers and InspectorsIndustries
Electromedical and Electrotherapeutic Apparatus ManufacturingSurgical and Medical Instrument ManufacturingIrradiation Apparatus ManufacturingRole Senior Human Factors / Usability Engineer supporting Bayer’s Radiology and Pharma device development.
Responsibilitiesdevelop and execute HF/UE strategies ensuring compliance with industry standards and regulations (IEC 62366-1, FDA guidance)
plan and lead usability evaluations across product lifecycle
conduct use-related risk analyses (URRA, UFMEA)
contribute to device requirements, UI design, and V&V activities
document HF/UE findings for design documentation and submissions
support regulatory interactions and stakeholder engagement
promote a user-centric approach within the organization.
Requirements:
Master’s in engineering, ergonomics, psychology, or related field with 4+ years (MS) or 7+ years (BS) HF/UE experience
expertise in regulated medical device development, risk analysis, and regulatory submissions, particularly with US FDA
strong understanding of IEC 62366-1, ISO 13485, ISO 14971, and EU MDR
excellent communication skills in English
ability to work in a global matrix environment.
High Valuemedical devices and combination products in radiology and pharma, with focus on usability, risk management, regulatory compliance, and user advocacy.
Work Setupbased in Indianola, PA, with potential for collaboration across Bayer’s global teams.
Apply now
Level
LeadL6
Location
New York, NY
Occupation
Human Factors Engineers and Ergonomists
Industry
Electromedical and Electrotherapeutic Apparatus Manufacturing
Posted
yesterday
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