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Human Factors Engineer Medical Device Jobs (NOW HIRING)

Arthrex

Human Factors Engineer II

Naples, FL · On-site

Human Factors Engineer II Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. The Digital Innovation team at Arthrex is ...

ARTHREX

Human Factors Engineer II

Naples, FL

Human Factors Engineer II Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. The Digital Innovation team at Arthrex is ...

Philips

Human Factors Engineer

San Diego, CA · On-site

$128K - $205K/yr

Strong experience in human factors and usability engineering within medical device development. * Proven track record of creating audit-ready usability documentation, including usability engineering ...

Philips

Human Factors Engineer

San Diego, CA · On-site

$128K - $205K/yr

Strong experience in human factors and usability engineering within medical device development. * Proven track record of creating audit-ready usability documentation, including usability engineering ...

Heartflow

Staff Human Factors Engineer

San Francisco, CA · On-site

$190K - $250K/yr

We are seeking an experienced Staff Human Factors Engineer to lead usability engineering across our AI-driven medical device portfolio. Reporting to the Sr. Director of Systems Engineering, you will ...

Heartflow

Staff Human Factors Engineer

San Francisco, CA · On-site

$190K - $250K/yr

We are seeking an experienced Staff Human Factors Engineer to lead usability engineering across our AI-driven medical device portfolio. Reporting to the Sr. Director of Systems Engineering, you will ...

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Human Factors Engineer Medical Device information

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How much do human factors engineer medical device jobs pay per hour?

As of Jun 11, 2026, the average hourly pay for human factors engineer medical device in the United States is $57.40, according to ZipRecruiter salary data. Most workers in this role earn between $42.79 and $67.55 per hour, depending on experience, location, and employer.

What is a Human Factors Engineer in the medical device industry?

A Human Factors Engineer in the medical device industry is responsible for ensuring that medical devices are safe, effective, and easy to use by considering how people interact with technology. They apply principles of human psychology, engineering, and design to optimize device usability and minimize user errors. Their work often includes conducting usability testing, analyzing user feedback, and collaborating with product development teams to ensure regulatory compliance and improve patient outcomes.

How do Human Factors Engineers collaborate with regulatory teams during the development of medical devices?

Human Factors Engineers frequently work alongside regulatory teams to ensure that medical devices meet stringent usability and safety requirements set by agencies like the FDA. This collaboration involves documenting user research, risk analyses, and validation studies to support regulatory submissions. Regular communication helps align design decisions with compliance standards, ensuring that the device is both user-friendly and legally marketable. As a result, Human Factors Engineers play a critical role in guiding the product through the approval process.

What are the key skills and qualifications needed to thrive as a Human Factors Engineer in Medical Devices, and why are they important?

To excel as a Human Factors Engineer in Medical Devices, you need a solid background in human factors engineering, usability testing, and regulatory knowledge, typically supported by a degree in engineering, psychology, or a related field. Familiarity with tools like usability testing software, prototyping platforms, and standards such as IEC 62366 is important, along with experience in documentation for FDA submissions. Strong analytical thinking, communication, and collaboration skills help in translating user needs into safe, effective device designs. These competencies ensure medical devices are user-friendly, compliant, and minimize risks to patient safety.

What is the difference between Human Factors Engineer Medical Device vs Human Factors Specialist Medical Device?

AspectHuman Factors Engineer Medical DeviceHuman Factors Specialist Medical Device
CredentialsBachelor's or Master's in Human Factors, Psychology, or Engineering; certifications like HF/E certificationSimilar credentials, often with additional certifications in usability or ergonomics
Work EnvironmentDesign teams in medical device companies, R&D labs, regulatory environmentsUsability testing labs, clinical settings, regulatory agencies
Industry UsageDesign and optimize medical devices for usability and safetyConduct usability assessments, risk analysis, and compliance documentation

While both roles focus on usability and safety in medical devices, Human Factors Engineers typically lead design and development, whereas Human Factors Specialists often focus on usability testing and compliance. Both roles require similar credentials and work within the same industry environment, but their specific responsibilities differ slightly.

More about Human Factors Engineer Medical Device jobs
What cities are hiring for Human Factors Engineer Medical Device jobs? Cities with the most Human Factors Engineer Medical Device job openings:
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Human Factors Engineer Medical Device jobs near you
Infographic showing various Human Factors Engineer Medical Device job openings in the United States as of June 2026, with employment types broken down into 70% Full Time, and 30% Contract. Highlights an 90% In-person, and 10% Remote job distribution, with an average salary of $119,382 per year, or $57.4 per hour.
Human Factors Engineer, Biotech Medical Device - REMOTE (JP11933)

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

3 Key Consulting

Thousand Oaks, CA • On-site, Remote

$55 - $75/hr

Other

Posted 19 hours ago

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 aHuman Factors Engineerfor 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 sendyour resume torecruiting@3keyconsulting.com. Ifyou decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our websitewww.3keyconsulting.com/careers. You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.

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