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Human Factors Engineering Study Manager (JP8304)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:  Human Factors Engineering Study Manager (JP8304)
Location: Thousand Oaks, CA. (Report pending COVID restrictions)
Employment Type:  Contract
Business Unit: Final Product Technologies – Usability Engineering
Duration: 1+ year (with likely extensions)
Posting Date: 3/2/21
 
 
3 Key Consulting is hiring a Human Factors Engineering Study Manager for a consulting engagement with our direct client, a leading global biopharmaceutical company.
 
Job Description:
The Human Factors Engineer (HFE) Study Manager is responsible for supporting activities related to human factors planning, stimuli implementation, study logistics, participant recruitment, study management, vendor liaison, data management and report generation. This person is expected to collaborate with internal and external partners and across functions with engineering, design, commercial, quality, and regulatory teams. The study manager will help to generate high quality studies and human factors data, providing critical support for product, labeling, packaging, instructional design, validation, clinical study, and regulatory submission activities.
 
 
Why is the Position Open?
Supplement additional workload on team.
 
 
Top Must-Have Skill Sets:
  • Master’s degree and 3 years of Human Factors Engineering, Usability Engineering, other Engineering in medical device or biotech industry experience OR Bachelor’s degree and 5 years of Human Factors Engineering, Usability Engineering, other Engineering in medical device or biotech industry experience
  • Experience supporting or leading various human factors methodologies such as planning, coordinating, conducting, analyzing and reporting ethnographic research, one-on-one interviews, contextual inquiries, use scenarios, focus groups, technical assessments, device UI evaluation, knowledge and comprehension studies, expert analysis, task analysis, hazard analysis, risk assessment, formative study and summative studies
  • Must have an ability to successfully work in device development environment that relies on design controls, cross-functional team decision making, and complex and challenging decision pathways.
 
 
Day to Day Responsibilities:
  • Support usability activities such as planning, protocol development, creation of data collection sheets, moderator scripts, stimuli material development, study coordination, IRB submissions, participant recruitment, study and vendor management, study observation, data collection, analysis, and documentation to support project needs
  • Collaborate with the human factors team, internal stakeholders and external suppliers to ensure that critical program decisions are implemented in a timely manner
  • Ensure that vendor partnerships are managed effectively so that bilateral expectations and synergies are achieved and valuable study data and learnings are gained
 
 
Employee Value Proposition:
Client is a leader in the biological pharmaceutical space, The Human Factors team has exposure to range of products. The role will challenge the HFE study manager on planning, managing, and collaborating with internal and external stakeholders.
 
 
Red Flags:
  • Only academic experience
  • Past experience exclusively in consumer or industrial product design
  • No medical device or drug-device experience
 
Interview process:
Video Skype Panel Interview
 
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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