Job Summary
The Human Factors Engineer brings expertise relating to the development of user needs, requirements, and iterative design based on the clinical use of medical devices. Responsible for providing Human Factors support across the product lifecycle including: leadership and coordination of usability studies for internal, formative, and summative assessments; collaboration with R&D team members to develop testable prototypes; partnering with Product Management and Clinical representatives to ensure alignment and development of user-centered designs; creation of test protocols, reports, and assessments; and ensuring local procedures alignment with current standards and FDA guidance. This position reports to the Director, Program Management and will support several medical device products within Fresenius Kabi.
Responsibilities:
- Support the product lifecycle through customer and user needs identification; development of user and workplace profiles and usage scenarios, use error analysis, and requirements; generation of hardware and software design concepts and user interface design.
- Develop Human Factors plans for new product development projects and Human Factors assessments for sustaining projects and define project scope and timing in partnership with Project Management.
- Plan and lead Human Factors / usability studies for hardware, disposables, software, and labeling product interfaces; analyze the data, document evaluation methods and results, and present design recommendations to the technical team.
- Lead the coordination of larger studies and recruiting activities with external consulting groups.
- Use appropriate Human Factors techniques to work with end users to determine end user behavior, preferences, and usage models and factor that information into requirements and usage scenarios.
- Conduct use-related risk analysis throughout all stages of product development.
- Ensure all activities are in compliance with IEC 62366, ISO 14971, and FDA Guidance on Human Factors, and Procedures and Work Instructions are appropriately updated to remain in compliance.
Requirements:
*Bachelor of Science in Human Factors Engineering, or similar related degree
*8 years' experience working in human factors
*Proven experience in applying human factors principles and methodologies to product development
*Clear working knowledge of IEC 62366, ISO 14971, and FDA Guidance on Human Factors
*High attention to detail
*Excellent oral and written communication skills
*Strong problem solving and organization skills
Additional Information:
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
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