Engineer II, Quality (Human Factors)
ICU Medical, Inc.

Job Info

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Job Description

Provide human factors support to the definition, design, evaluation, and validation of ICU Medical product development. The Human Factors Engineer will ensure compliance with the 2016 FDA Human Factors guidance and IEC 62366. Also, the Human Factors Engineer will interact with Human Factors consultants to conduct formative and summative tests.

Essential Duties & Responsibilities

• Working under supervision, plan, schedule, conduct and coordinate human factors activities.

• Provide human factors support for product development, including developing user profiles, identifying user needs, analyzing user tasks, and identifying and managing use-related risk.

• Participate in translating user needs and requirements into design concepts. Create or contribute to the creation of mockups and prototypes.

• Under supervision, plan and conduct formative usability evaluations and summative validation tests, analyze data, document results, and present recommendations to product teams.

• Interact with human factors consultants to conduct formative and summative tests.

• Create documentation related to human factors activities needed for regulatory compliance.

• Effectively interact with multi-disciplinary teams, including engineering, marketing, regulatory, and clinical areas.

• Actively contribute ideas for improvement and collaboration.

Knowledge and Skills

• Knowledge of the theories, principles, and data associated with human performance capabilities and limitations (perceptual, cognitive, motor, biomechanical, and anthropometric).

• Ability to apply human factors principles and methods to the design, definition, evaluation, launch, and use of medical devices.

• Knowledge of ISO 14971 and experience developing use-related risk analyses (URRAs).

• Knowledge of medical device Human Factors guidance and standards, including FDA, IEC 62366, and MDR.

Minimum Qualifications, Education and Experience

• Must be at least 18 years of age.
• High School diploma: Bachelor's degree in Human Factors, Cognitive/Experimental Psychology, Industrial Engineering, Biomedical Engineering or related field from an accredited college or university is required.
• M.S. or Ph. D degree in Human Factors or related field is preferred.
• 2 - 4 years of experience in Medical Device Human Factors is required.

Work Environment

• This is largely a sedentary role.

• This job operates in a professional office environment and routinely uses standard office equipment.

• Typically requires travel 5% to 10% of the time.

About Us

ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.

With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.

We're ready to bring you consistent quality, innovation, and value in more areas than ever. Our focus allows us to bring you:

• Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
• The industry's broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
• IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
• Significant US IV solutions manufacturing and supply capabilities.

ICU Medical EEO Statement:

ICU Medical is committed to fostering a diverse, inclusive, and equitable work environment. As an Affirmative Action and Equal Opportunity Employer, we ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender identity, gender expression, gender reassignment, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.

If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.

ICU Medical EEO Policy Statement

OFCCP Equal Opportunity Posters

"Know Your Rights" Poster
Pay Transparency Nondiscrimination Provision

ICU Medical CCPA Notice to Job Applicants

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