Remote Sr. Human Factors Engineer

Insights & Human Factors Blue Ash, Ohio

The Senior HFE will have demonstrated and in-depth knowledge of human factors design principles and usability testing methods, as well as a keen understanding of the product development process required for consumer and industrial products, as well as U.S. and EU health authorities’ requirements for design controls for medical device development. This is a position that can work remotely. 

 Working cross-functionally across the Kaleidoscope organization, the Senior HFE will lead human factors activities that includes activities planning, use-related risk management, design research, and formative and summative usability testing and reporting. The Senior HFE directly contributes to research efforts by participating on client core teams, leading, planning, authoring, and executing research, and analyzing resultant data and recommendations leading to opportunities for product improvement, enhancement, and innovation.

At Kaleidoscope Innovation, we recognize and celebrate individual talent and we understand the importance of letting individuals be just that. Our people are here to do the best work of their lives and our job is to provide the platform for them to do it. That means letting people pursue the projects that interest them and develop their career in whatever direction they choose.


PRINCIPAL DUTIES & RESPONSIBILITIES

  • Manages customer expectations by delivering within expected budgets, timelines and project hours based on a project statements of work
  • Manages and executes coordinated HFE/UE scheduling and technical requirements with internal core teams, I/HF project schedules and customer expectations
  • Ensures on-time delivery, accurate and high quality HFE/UE project deliverables for self, as well as other HFE/UE colleagues
  • Keeps the Director, I/HF and applicable managers and leads apprised of any potential foreseen project constraints and/or issues pertaining the on-time delivery and/or quality of project deliverables
  • Identifies customer needs and proposes innovative solutions
  • Leads in developing the authoring of usability plans and user needs specifications, hazard analyses, task analyses, use error and risk analyses, expert reviews, heuristic evaluations and usability verification and validation for client products (as applicable)
  • Designs and executes studies and report observations and findings for usability studies at various stages of product development from early prototypes through formative and summative formal health authority-mandated requirements and guidance.
  • Leads observational, ethnographic, surveys, in-person and remote, as an example, research as needed to uncover unmet needs
  • Collaborates in project core and brainstorming teams
  • Manages client feedback process including analyzing, summarizing and reporting data for the company
  • Synthesizes and assembles relevant information into an appropriate format for the project (e.g. Excel, PowerPoint)
  • Ensures knowledgeable about relevant category, product or company to inform SOW development, project deliverables and project team efforts prior to project kickoff
  • Proactively searches for articles, studies, journals, etc. to assist with development of client deliverables

Summary of main duties but not exhaustive listing.

QUALIFICATIONS

  • Education/Experience Completion of a Master or Bachelor of Science (or higher) in Human Factors, Experimental Psychology, Cognitive Psychology, Cognitive Science, Industrial Design, Human-Computer Interaction, or related fields
  • 2-6+ years of professional experience, preferably in medical device development
  • Experience with all phases of the product development life cycle including feasibility, planning, requirements, design and development, verification and validation, design freeze and phase gates, and design transfer strongly preferred
  • Moderate understanding of FDA Quality System Regulation, ISO 13485, ISO 14971, Medical Device Regulations (MDR), IEC 62304 and IEC 62366 requirements strongly preferred

Requirements

  • Experience with Human Factors/Usability in medical devices and familiarity with existing IEC Usability standards, AAMI Human Factors standards and/or FDA Human Factors Guidance
  • Expertise in user-facing activities and interacting with clinicians, preferred
  • Utilize excellent communication and presentation skills in all settings to include executive level feedback, teammates, clients and peers within the product development process.
  • EEO/M/F/Disabled/Vet