Human Factors Engineer, Biotech Medical Device - REMOTE (JP11933)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 2, 2026
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Job Description:
Job Title: Human Factors Engineer, Biotech Medical Device -
REMOTE (JP11933) Location: Thousand Oaks, CA. 91320 (100% REMOTE)
Business Unit: Combination Product Excellence Employment Type:
Contract Duration: 1 years with possible extensions or conversion
to FTE Rate : W2 $55 - $75 or Market Rate Posting Date: 10/24/2023
3 Key Consulting is recruiting a Human Factors Engineer for a
consulting engagement with our direct client, a leading global
biotechnology company. Job Description: Manager would like to see
writing samples if available. Successful candidate understands
human factors engineering and has 4 YOE prior HFE experience (not
including academic. this must be industry experience). Ability to
work autonomously. Is a critical thinker, detail oriented, and a
great communicator. Manager prefers Bachelors or greater in human
factors engineering or biomedical engineering or mechanical
engineering. Description: The Human Factors Engineer (HFE) /
Usability Engineer (UE) contractor is responsible for supporting
HFE/UE planning, research, development of drug delivery devices
using HFE/UE best practices and in accordance with current
regulations and guidelines within the medical device, combination
product and bio-pharmaceutical industries. This person is expected
to collaborate with internal and external partners and across
engineering, design, commercial, quality, and regulatory teams.
This person will support human factors research driving innovative,
intuitive, and useful products. The HFE contractor will support
project study design and methodology. This person will lead study
data collection, root cause analysis and report writing to inform
design and apply sound HFE/UE knowledge and experience to research,
development, clinical studies, product validation in support of
regulatory submissions. Top Must Have Skill Sets: Author end-to-end
HFE documents for regulated medical devices; Superb technical
writer and communicator; and Experience leading HFE studies,
including planning, writing protocols, moderating, note taking,
analyzing and reporting. Day to Day Responsibilities: Work
collaboratively with HFE, engineering, design, commercial, and
product teams to ensure successful translation of user requirements
into products, to create user interface (UI) requirements, that
meet the needs of users and enrich the overall user experience
across client’s portfolio or programs. To support usability
activities such as planning, protocol development, data collection
sheets, moderator scripts, material development, study
coordination, IRB submissions, participant recruitment, study
management. Analyze objective and subjective data from usability
studies to inform design, inform risk minimization, and provide
alternative solutions. Prepare documentation to support development
activities, design controls, DHF, DMR including protocols, task
analysis, risk assessment, HFE technical assessments, HFE reports,
and regulatory submissions. Actively communicate with internal and
external key stakeholders. Basic Qualifications: Master’s degree in
Engineering OR Bachelor’s degree in Engineering and 2 years of
experience Preferred Qualifications: Bachelor’s degree in
Engineering and 4 years of experience Why is the Position Open?
Supplement additional workload on team Red Flags: University
graduate work does not contribute to years worked. Less than 4
years of human factors medical device or combination product work
experience. Moves between jobs frequently. Interview Process:
Hiring team will review resumes and identify candidates for initial
30-min VC interview. Following phone interview, 1-2 group
interviews lasting 45-min VC interview. Discussion with senior
leadership and director of HFE. Decision to hire or not. We invite
qualified candidates to send your resume to
recruiting@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
Keywords: 3 Key Consulting, Rancho Palos Verdes , Human Factors Engineer, Biotech Medical Device - REMOTE (JP11933), Engineering , Thousand Oaks, California
