Human Factors Engineer II

Fresenius Medical Care - Waltham, MA (30+ days ago)3.6


Global Research & Development
Our Global Commitment to Deliver
Around 3 million individuals worldwide suffer from renal failure. With innovative products and therapies we define highest standards for the dialysis treatment of patients with chronic kidney failure and extracorporeal therapies for organ support.
Our Global Research & Development (GRD) activities enable us to develop products efficiently and to systematically promote the exchange of knowledge and technology between regions. Our intention to develop innovative products that are not only of the highest quality, but are also affordable so that caregivers and patients can benefit from them.
Click to Learn more about the Global Research and Development Organization!

PURPOSE AND SCOPE:
Supports the development of products by working collaboratively with interdisciplinary teams to plan, direct, and (where applicable) 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 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:

Supporting and/or directing R&D, Clinical, Marketing, and other staff regarding human factors considerations
Supporting and/or 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 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, and participates in 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 collaboration with 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.
Normally receives general work instructions on routine work, detailed instructions on new projects or assignments.
Works on problems of moderate scope where analysis of situation or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action.
Builds productive working relationships.
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.
Assists with various projects as assigned by 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 20-25% travel is expected of this position.

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 2 – 5 years of general human factors/usability experience and/or medical human factors experience; with an advanced degree no prior work experience may be considered.
Demonstrated experience in a human factors/usability role in new product development.
Strong interpersonal skills with the ability to communicate with all levels of management with diplomacy and tact.
Ability to work mostly independently with a moderate level of supervision.
Ability to address issues and solutions in clear and concise written and verbal communication.
Comprehensive knowledge of Human Factors Engineering.
Prior experience with human factors analyses and 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 of interdisciplinary collaboration with R&D, Quality, Regulatory, Marketing and other functions.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity