Senior Human Factors Specialist

2 weeks ago


Charlotte, North Carolina, United States Genovice Full time
Job Overview

The Senior Human Factors Specialist at Genovice is tasked with delivering expert consultation and leadership in human factors activities. The role primarily involves developing study protocols, moderating studies, and generating reports. A key differentiator for this position is the significant hands-on involvement in projects, paired with high-level program management. The work environment is dynamic and fast-paced, requiring collaboration with multiple clients and handling various programs simultaneously.

Key Responsibilities
  • Oversee multiple projects at different phases of human factors processes, from early development to late-stage product evaluation.
  • Plan, execute, and report on human factors activities for client programs, including moderating studies or assisting others as needed.
  • Stay up-to-date on human factors practices, methodologies, and regulatory requirements to ensure alignment with industry developments.
  • Manage third-party contractors and vendors, such as recruiters and study facilities.
  • Ensure project timelines and budgets are met according to client agreements.
  • Identify and communicate new business opportunities to support client needs and contribute to business development goals.
  • Provide mentorship and support to team members as necessary.
  • Perform duties in compliance with the company's Quality Management System.
Requirements
  • Advanced degree in Human Factors or a closely related field.
  • Extensive knowledge of the healthcare sector, including device use and the responsibilities of stakeholders.
  • At least seven years of experience conducting exploratory, formative, and validation (summative) human factors studies for medical devices and combination products.
  • Experience developing use-related risk documents for medical devices, particularly in conducting Use-Related Risk Analyses in line with FDA guidance.
  • Familiarity with human factors standards and guidelines relevant to medical devices (e.g., FDA/CDER, FDA/CDRH, IEC 62366, HE 75).
  • Strong skills in developing human factors testing protocols, from flexible formative protocols to structured validation protocols.
  • Proven project management capabilities, with the ability to prioritize and manage several projects concurrently.
  • Proficiency in moderating studies, particularly those involving sensitive topics or inexperienced participants, while ensuring data collection and participant comfort.
  • Ability to work independently with minimal supervision in a remote work setting.
  • Demonstrated teamwork and leadership skills.
  • Excellent communication, presentation, and technical writing skills.
  • Strong analytical, problem-solving, and organizational abilities; self-motivated and quick to learn.
  • Willingness to travel across North America for study moderation, approximately five days a month.
Benefits

Genovice offers a comprehensive benefits package, including health benefits, paid time off, and paid holidays.



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