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PURPOSE AND SCOPE:

Acts as a subject matter expert to support the development of products by working collaboratively with interdisciplinary teams to plan, direct, and (where applicable) perform human factors/usability engineering activities. Serve as a leader in the design and evaluation of processes, products, and systems with respect to human factors/usability considerations (i.e. how intended users interact with systems given their goals, tasks, and environment).

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Technically proficient subject matter expert and technical leader in human factors engineering responsible for lifecycle application of human factors design process, principles, analysis, and usability testing methods

• Develops collaborative working relationships with a range of functions including, but not limited to R&D, Marketing, Quality, Regulatory and Clinical functions

• Provides technical guidance and/or design expertise to a wide variety of contexts including, but not limited to:

• Directing R&D, Clinical, Marketing, and other staff regarding human factors considerations

• Directing the definition and development of system user interface design(s)

• Supporting the definition and development of labeling and training

• Contributes to user interface designs by providing guidance, ideas, and review to UX designers and developers.

• Collaborates with peers and other staff on human factors processes and principles

• Ensures that development plans, processes and activities address human factors engineering process and design requirements in order to maximize product usability and use-related safety.

• Identifies user needs/requirements, and collaborates with product management/marketing to ensure designs meet the user and customer needs.

• Collaborates with development teams to optimize designs in consideration of use error risk and overall usability. Leads and authors the identification, analysis, and evaluation of use-related risk and development of risk controls.

• Responsible for planning and conducting human factors analyses, unstructured testing, and structured usability studies. This may involve directing others or personally executing study/protocol design, study execution, data collection and analysis, as well as writing study reports and communicating findings and recommendations to teams.

• Contributes to the design development process by participating in design review meetings, reviewing and contributing to design inputs, risk analysis, and reviewing and testing new product performance.

• Applies persuasion to change the thinking of and/or gain acceptance from others in sensitive situations while maintaining an effective working relationship.

• Oversees the monitoring, completion and accuracy of documents produced by human factors engineering activities.

• Responsible for HF assessments included in regulatory documents submitted to the FDA (or other regulatory bodies).

• Responsible for ensuring compliance to applicable standards and guidance.

• Contributes to human factors process development and improvements and development of associated templates.

• Responsible for keeping current on new developments in human factors engineering.

• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise.

• Normally receives little instruction on day-to-day work, general instructions on new assignments.

• May provide assistance to lower-level staff with more complex tasks that require a higher level of understanding of functions.

• May escalate issues to supervisor/manager for resolution, as deemed necessary.

• Mentors other staff as applicable.

• Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.

• Assists with various projects as assigned by a direct supervisor.

• Other duties as assigned.

Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

• The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Approximately up to 20-25% travel is expected of this position.

SUPERVISION:

None, although will typically serve as a lead for human factors engineering on project cross-functional teams.

EDUCATION:

• Bachelor’s Degree required; Advanced Degree preferred

• Degree in Human Factors Engineering, Industrial Engineering, Human-Computer Interaction, Cognitive Psychology, or related field with relevant work experience demonstrating acquisition and application of position-relevant skills.

EXPERIENCE AND REQUIRED SKILLS:

• Minimum 9+ years of human factors/usability experience required.

• Demonstrated experience leading human factors/usability in new product development.

• Strong interpersonal skills with the ability to communicate with all levels of management with diplomacy and tact.

• Ability to work independently with minimal supervision

• Ability to address issues and solutions in clear and concise written and verbal communication

• Comprehensive knowledge of Human Factors Engineering

• Prior experience developing regulated medical devices, including performing human factors analyses and designing and executing formative and summative human factors usability studies.

• Familiarity with relevant quality regulations (21 CFR Part 820.30), human factors/usability engineering standards (IEC 62366-1, ANSI HE75, ISO 14971), and FDA guidance

• Track record of interdisciplinary collaboration with R&D, Quality, Regulatory, Marketing and other functions.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.