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Perform usability assessments per IEC 62366 and other global and internal standards and procedures for new and existing products including hazard identification, risk analysis, and applicable human factors analysis.
Documentation of effort required to support filings to regulatory bodies.
Understand and assess user needs and motivations uncovered in research.
Create experimental design concepts and prototypes.
Conduct usability testing such as planning, protocol development, data collection sheets, moderator scripts, material development, study coordination, IRB submissions, managing participant recruitment, study management, data collection, analysis, and documentation in technical reports to support project needs.
Analyze objective and subjective data from usability studies to inform design and provide alternative solutions. Present results to cross-functional teams with recommendations.
Ensure product quality and all tasks are in accordance with established SOPs, GMPs, Divisional Specifications, and EHS standards.
Operate as an engineering lead on projects when needed.
Medical Device Engineer II, Usability
Rochester, NY$65K - $95K / yearPosted 1 months ago
Full-timeonsitemid