Massachusetts Jobs

PURPOSE AND SCOPE:

Supports the development of products by working collaboratively with interdisciplinary teams to support and/or perform human factors/usability engineering activities. Supports 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 human factors engineering professional supporting 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 human factors engineering support and assistance to more senior human factors staff.

• May contribute to user interface designs by providing ideas and review to UX designers and developers.

• Collaborates with peers and other staff on human factors activities in support of projects.

• Assists more senior human factors staff in order to help ensure development plans, processes, and activities address human factors engineering process and design requirements in order to maximize product usability and use-related safety.

• Collaborates with other Human Factors staff to help ensure that designs meet the user and customer needs.

• Participates in identification, analysis, and evaluation of use-related risk and development of risk controls.

• Responsible for conducting human factors analyses, unstructured testing, and structured usability studies. This may involve study/protocol design, study execution, data collection and analysis, as well as writing study reports and communicating findings and recommendations to teams, typically in collaboration with more senior Human Factors Engineering staff.

• Assists with the monitoring, completion, and review of documents produced by human factors engineering activities.

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

• Assists more senior Human Factors staff in achieving compliance with applicable standards and guidance.

• Supports development of templates.

• Supports study participant recruiting.

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

• Works on problems of limited scope. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.

• Builds stable working relationships internally.

• Normally receives specific, detailed instructions on all work.

• May senior level staff, if applicable, for assistance with day-to-day problems that may arise.

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

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

• 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 15-20% travel is expected of this position.

EDUCATION:

Bachelor’s Degree required in Human Factors Engineering, Industrial Engineering, Human-Computer Interaction, Cognitive Psychology, or related field with relevant work experience demonstrating ability to fill any gaps in position-relevant skills.

EXPERIENCE AND REQUIRED SKILLS:

• Minimum 0 – 2 years of related experience.

• Strong interpersonal skills with the ability to communicate with tact.

• Ability to work well under a moderate level of supervision.

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

• Knowledge of Human Factors Engineering.

• Some prior experience with human factors analyses and/or designing and executing usability studies.

• Ability to become familiar 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 indicating ability to work collaboratively across functions (i.e. R&D, Quality, Regulatory, Marketing, 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.