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

Job Info

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Position Summary

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.

ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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