Job Description
Title: Human Factor Engineerin
Location: Plymouth, Minnesota 55441. HYBRID.
Duration: 12 months with the possibility of extension/conversion
Job Description
- The Lead Human Factors Coordinator role is responsible for coordinating Human Factors studies from initiation through completion. Additionally, this role supports the HF team during the Human Factors/usability engineering process and develops study coordination procedures to improve effectiveness, speed and digitalization of study planning and HF team internal communication.
Essential Duties and Responsibilities
Leading/Supervising:
- Lead the planning and organization of Human Factors study logistic-relevant work to keep a smooth study preparation and execution process, including (but not limited to) participant recruiting, ordering and shipping supplies/equipment, communication with third-party personnel, negotiating quotes with vendors providing study service, developing statement of work, processing non-disclosure agreements and payment, note-taking, data transcription & verification, etc
- Responsible for communication with Ethics &Compliance (E&C), Legal and Regulatory team members to advise HF Engineers on study timeline, project costs, Client established Fair Market Value rates, vendor contracts, local/global interaction policies/laws and regulations across different countries and regions. Develop and maintain job aids to guide HF Engineers on relevant legal/E&C processes
- Design, deploy and maintain HF team site for information and process digitalization. Instruct HF Engineers and/or study coordinators on study planning & coordination process. Advise on internal E&C policies and processes for holding HF studies with HCPs in the U.S. and OUS. Advise on required study contracts.
Supporting:
- Perform study budget estimations and track and monitor project budgetary commitments
- Actively reduce study risks through problem identification, contingency plans and escalation
- Collaborate with HF Engineers to assess vendor capabilities, work with procurement to onboard new vendors, and update internal supplier list.
Qualifications:
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.
- Familiar with the standard Human Factors/usability engineering process
- Ability to manage simultaneous HF study logistics to meet established timelines within approved budgets
- Strong interpersonal and communication skills
- Ability to act independently, make decisions and solve coordination work problems with minimal assistance
- Fluent in general MS Office tools
- Able to proactively improve processes, initiate projects and implement changes
Education and/or Experience:
- Include the education and/or experience that is necessary to perform the job satisfactorily.
- Bachelor’s degree in engineering or relevant field
- 1+ year experience in medical device industry preferred