Job Description

Overview

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

Successful candidate understands human factors engineering and has 4+ years of industry HFE experience (not including academic). Must be able to work autonomously, be a critical thinker, detail oriented, and a great communicator. Manager prefers a Bachelor or higher in human factors engineering or biomedical engineering or mechanical engineering.

The Human Factors Engineer (HFE) / Usability Engineer (UE) contractor is responsible for supporting HFE/UE planning, research, and the development of drug delivery devices using HFE/UE best practices 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 across engineering, design, commercial, quality, and regulatory teams. They will support human factors research driving innovative, intuitive, and useful products. The HFE contractor will support project study design and methodology, lead study data collection, root cause analysis and report writing to inform design and apply sound HFE/UE knowledge to research, development, and 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 translate user requirements into products and create UI requirements that meet user needs across the client’s portfolio or programs.
• Support usability activities such as planning, protocol development, data collection sheets, moderator scripts, material development, study coordination, IRB submissions, participant recruitment, and study management.
• Analyze objective and subjective data from usability studies to inform design, 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-minute VC interview. Following a phone interview, 1-2 group interviews lasting 45 minutes VC interview. Discussion with senior leadership and director of HFE. Decision to hire or not.

We invite qualified candidates to send your resume to the recruiting email above. If you’re not interested in pursuing this position, please consider other opportunities on our website at 3keyconsulting.com/careers. You may also share this opportunity with someone who might be interested in applying for this role.

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