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Human Factors Engineer Medical Device Jobs in Colorado

Blue Origin

Sr. Human Factors Engineer

Denver, CO · On-site

As a Human Factors Engineer (HFE) within ACE, part of a small, passionate, and accomplished team of ... Medical, dental, vision, basic and supplemental life insurance, paid parental leave, short and ...

Blue Origin

Lunar Human Factors Engineer

Denver, CO · On-site

As a human factors engineer on Blue Origin's Lunar program, you will serve as a technical lead for ... Medical, dental, vision, basic and supplemental life insurance, paid parental leave, short and ...

Medtronic

Sr User Experience Engineer

Lafayette, CO · On-site

Knowledge of IEC 62366, Food and Drug Administration Human Factors guidance, and medical device ... Experience aligning engineering execution with portfolio strategies, product roadmaps, and ...

Medtronic

Sr User Experience Engineer

Lafayette, CO · On-site

Knowledge of IEC 62366, Food and Drug Administration Human Factors guidance, and medical device ... Experience aligning engineering execution with portfolio strategies, product roadmaps, and ...

Medtronic

Sr User Experience Engineer

Lafayette, CO · On-site

Knowledge of IEC 62366, Food and Drug Administration Human Factors guidance, and medical device ... Experience aligning engineering execution with portfolio strategies, product roadmaps, and ...

LivaNova, PLC

Medical Device Assembler

Arvada, CO · On-site

$19.50 - $21/hr

Medical Device Production Assembler Build Products That Help Change Lives Arvada, CO | Full-Time ... Collaborate closely with engineering, quality, and operations teams. * Take ownership of your work ...

LivaNova

Medical Device Assembler

Arvada, CO

$19.50 - $21/hr

Medical Device Production Assembler Build Products That Help Change Lives Arvada, CO | Full-Time ... Collaborate closely with engineering, quality, and operations teams. * Take ownership of your work ...

Actalent

Electrical Engineer

Highlands Ranch, CO

$120K - $160K/yr

Experience in medical device or other regulated environments, with familiarity in complying with ... Individual compensation offered for this position within this range will depend on many factors ...

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All JobsHuman Factors Engineer Medical Device JobsHuman Factors Engineer Medical Device Jobs in Colorado

Human Factors Engineer Medical Device information

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.

Are human factors engineers in demand?

Human factors engineers in medical devices are in high demand due to increasing focus on user safety, device usability, and regulatory compliance. They often work in healthcare, technology, and manufacturing sectors, utilizing skills in ergonomics, usability testing, and regulatory standards like FDA guidelines.

How much does a human factors engineer medical device make?

A human factors engineer in the medical device industry typically earns between $80,000 and $130,000 annually, depending on experience, education, and location. Senior roles or those with specialized skills in usability testing and regulatory standards can earn higher salaries, often exceeding $150,000.

What are popular job titles related to Human Factors Engineer Medical Device jobs in Colorado?

For Human Factors Engineer Medical Device jobs in Colorado, the most frequently searched job titles are:

What job categories do people searching Human Factors Engineer Medical Device jobs in Colorado look for?

The top searched job categories for Human Factors Engineer Medical Device jobs in Colorado are:

What cities in Colorado are hiring for Human Factors Engineer Medical Device jobs?

Cities in Colorado with the most Human Factors Engineer Medical Device job openings:

Human Factors Engineer Medical Device jobs near you

Engineer 3 - Human Factors

Terumo BCT, Inc.

Lakewood, CO • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 9 days ago

Key responsibilities

  • Lead the strategy, planning, and execution of human factors engineering activities and validation for new and sustaining product development projects.

  • Conduct user-centered research, including interviews, task analyses, and usability evaluations, to develop user and environment profiles and usability requirements.

  • Collaborate with cross-functional teams to create and maintain use-related risk analyses and support prototype development of user interfaces.

Job description

Requisition ID: 35321
At Terumo Blood and Cell Technologies, our 8,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere.
We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient's life every second of every day and are committed to continuing to increase the number of patients we serve. Advancing healthcare with heart.
With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Join us and help shape wherever we go next. You create your future and ours.
Engineer 3 -Human Factors
JOB SUMMARY
Work requires originality and judgement in performing independent human factors research, analysis, and evaluation using standard human factors engineering (HFE) theories, principles, and data to facilitate user-centered product design and development. Performs work which requires a broad knowledge of engineering precedents in the specialty area and a good knowledge of principles and practices of related specialties.
The Human Factors Engineer 3 will apply HFE to system user interface definition, design, and evaluation for new product development, as well as support sustaining and innovation projects. Duties are assigned to provide experience and familiarization with engineering methods, independent thinking, leadership opportunities, and company practices and policies.
ESSENTIAL DUTIES
  • Leads the strategy, planning, and execution of human factors engineering activities and HF validation for new product development projects of all sizes and sustaining projects with impacts to the user interface.
  • Advises, reviews, and approves HF impact assessments for product design changes.
  • Conducts user-centered research including interviews, contextual inquiries, task analyses, and anthropomorphic evaluations for development of user and environment profiles, use specification, use cases, and usability/user interface requirements.
  • Exercises independent judgment in usability testing methodology, data collection, data analysis, conclusions, and design recommendations at various stages of product development from early prototypes through formal validation testing.
  • Ensures that product development projects are following HFE process compliant with all Company policies and procedures as well as existing IEC Usability standards, AAMI Human Factors standards and/or FDA and NMPA Human Factors Guidances.
  • Analyzes field data and reviews literature and publications to identify existing usability issues with on-market products.
  • Works with cross-functional teams to create and maintain use-related risk analyses and user interface requirements.
  • Actively collaborates in prototype development of user interfaces, including software, graphical user-interface, hardware or disposable components, and labeling and training.
  • Supports the development of internal tools for human factors data capture, analysis, and testing.
  • Contributes to identifying and developing design and development process improvements and best practices.
  • Reinforces customer empathy and human-centered design approach across the organization.
  • Keeps abreast of regulations and best practices for medical device human factors engineering (e.g. IEC 62366, AAMI HE75, FDA Applying Human Factors and Usability Engineering to Medical Devices).

OTHER DUTIES AND RESPONSIBILITIES
  • Responsibilities may include providing work direction to technicians and junior engineers.
  • Collaborate with other functional groups, technical disciplines, and levels of management including other engineering disciplines such as Systems and Software Systems, UX Designers, Product Technology Leads, Marketing, Regulatory, Project Managers, Global Services, and Global Product Support and Training.

MINIMUM QUALIFICATION REQUIREMENTS
Education
  • Bachelor's degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
  • Bachelor of Science Degree in Usability/Human Factors Engineering, Biomedical Engineering, Systems Engineering or related research-based degree, preferred.

Experience
  • Minimum 4 years experience.
  • Experience with Human Factors/Usability in medical devices and familiarity with existing IEC Usability standards, AAMI Human Factors standards and/or FDA Human Factors Guidance, preferred.
  • Experience with risk management activities for medical devices, specifically those applied by Human Factors (i.e. URA, UFMEA, AFMEA, UEA techniques), preferred.

Skills
  • Demonstrated skills in engineering and technical leadership in the design and development of medical devices.
  • Requires working knowledge of human factors, design controls, quality, and risk management regulations, standards, and guidances for medical devices.
  • Requires strong interactive skills in general communication, cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross-functional team members, team behavior.
  • Provides support for subordinates, junior engineers, technicians, and management.
  • Ability to influence without authority to drive user-centered design across functional partners.
  • Ability to moderate usability studies in a manner that produces reliable data with minimal bias.
  • Ability to be innovative in approaches to accomplishing user-centered design and design for usability.
  • Strong technical writing skills to produce human factors protocols and reports for regulatory requirements and submissions.
  • Strong critical-thinking and problem-solving skills in diagnosing root causes of human factors issues and recommend user-centered design solutions.
  • Highly organized and able to work efficiently across multiple projects in parallel.
  • Demonstrated ability to communicate and present data and results effectively verbally, in writing, and through presentations to both technical and non-technical audiences.
  • Knowledge and use of relevant PC software applications and skills to use them effectively.

-Or-
An equivalent competency level acquired through a variation of these qualifications may be considered.
PHYSICAL REQUIREMENTS
General Labor Environment requirements include: use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment.
The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
Additional Physical Requirements
Requires domestic and international travel based on business needs.
Target Pay Range: $109,800.00 to $137,200.00 - Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data
Target Bonus on Base: 7.0%
We anticipate this requisition will be open for a minimum of five days, from . We encourage your prompt application.
At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it's about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.
  • Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
  • In 2024, Terumo Blood and Cell Technologies reached $1.5 billion in revenue.
  • We employ nearly 8,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
  • We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries.
  • Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare.
    • Respect - Appreciative of others
    • Integrity - Guided by our mission
    • Care - Empathetic to patients
    • Quality - Committed to excellence
    • Creativity - Striving for innovation
  • We contribute to the Leukemia and Lymphoma Society (LLS), raising $2.4 million USD since 2025.

We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.
Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment. Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.

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