3 Key Consulting, Inc.

Human Factors Engineer, Biotech Medical Device - REMOTE (JP11933)

3 Key Consulting, Inc.  •  Thousand Oaks, CA (Remote)  •  19 days ago
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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.


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.


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.
3 Key Consulting, Inc.

About 3 Key Consulting, Inc.

3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries. With 12 years of experience, 3Key has established a vast network of industry professionals and forged strong partnerships/alliances with key academic institutions across the country to continually develop our business professional and niche skill pipeline.

3KC offers a full suite of staffing solutions including PEO and compliance services. 3KC has several technology and industry domain practices including competencies in business intelligence, healthcare and life sciences.

People, process, and technology are 3 key areas of focus that we carefully examine individually and jointly, in order to deliver on our client's 3 key areas of focus - better, faster and cost effective BI and staffing solutions.

MISSION:

To create a better work experience for our customers, partners and employees through exceptional dedication and performance.

• We make hiring easier

• We build strong teams

• We bring about positive outcomes

VISION:

3 Key Consulting’s responsibility is to continually improve the manner and efficiency in which human resources and businesses are brought together to create value. Our vision is to put programs into action that improve market efficiencies while helping businesses and people be more productive.

Industry
Unknown
Company Size
1-10 employees
Headquarters
Simi Valley, CA
Year Founded
2009
Website
3keyconsulting.com
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