Job Description
Brief Description About ECI ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.
About The Role The Human Factors Engineer -Medical Devices will be responsible for applying human factors engineering principles and ergonomics principles to test and optimize products and systems. Your expertise will contribute to enhancing user experience, improving safety, and increasing overall efficiency. As a Human Factors Engineer, you will ensure that products and systems are designed with the end-users in mind and meet the highest standards of usability, safety, and efficiency. This role will be responsible for conducting a usability study with the following activities and deliverables:
- Risk Analysis and Protocol Development
- Collaborate with the client to conduct a Risk Analysis to identify critical tasks and associated risks for both adult and pediatric users.
- Develop a study protocol that addresses both usability and regulatory needs, tailored for a pediatric indication to meet FDA standards.
- Recruitment Planning
- Design a detailed Moderator Guide with questions for subjects, structured for non-bias and consistency. Develop a recruiting script used to recruit participants which contains criteria for participation.
- Usability Study Execution
- Data Analysis and Reporting
- Analyze usability testing results, focusing on task completion, areas where users struggled, and adherence to protocol.
- Usability File Documentation
- Deliverables:
- Risk Analysis Report – Document identifying critical tasks, associated risks, and regulatory considerations.
- Usability Study Protocol – Comprehensive protocol document that includes participant recruitment criteria, user tasks, and a structured Moderator Guide
- Recruitment Plan – Detailed recruitment approach outlining participant selection and questionnaire.
- Moderated Usability Testing Sessions – Conducted sessions with recorded audio/video files for further analysis.
- Usability Study Report – Final report summarizing testing outcomes, insights into user performance, and identified areas of difficulty.
- Complete Usability File – Organized file with protocol, results report, task analysis, and training level impacts, meeting FDA usability documentation requirements.
- Duration of Project is approximately 4 months
- Testing will be conducted will be in the Boston, Chicago and additional metro area that is to be determined
What We Look For - Bachelor's Degree in Engineering (biomedical, mechanical, industrial or other related degree)
- 6+ years Usability / Human Factors experience in the medical devices industry
- Advanced computer skills including MS Office applications (Word/ Excel/ PowerPoint/ Project/ Visio)
- Experience in the following Human Factors activities:
- Collaborating on Task & Use Error Analysis
- Authoring usability study reports
- Performing recruitment tasks
- Usability testing data collection
- Ability to analyze and write up reports
- Leading skills such as strong verbal and written communications, aligning to the project's schedule, and managing the day-to-day progress independently.
- Local to greater Boston or Chicago areas a plus
Job Tags
Local area, Flexible hours,