Fresenius Medical Center Application Information Architect in Waltham, Massachusetts

PURPOSE AND SCOPE:

Supports the development of products by working collaboratively with interdisciplinary teams to apply information architecture principles, methods and activities to the design and evaluation of information for medical devices/systems. In collaboration with Human Factors Engineers, supports the design and evaluation of systems with respect to information architecture and human factors/usability considerations (i.e. how intended users interact with systems given their goals, tasks, and environment).

PRINCIPAL DUTIES AND RESPONSIBILITIES:

  • Technically proficient professional responsible for lifecycle application of information architecture principles and activities to the development of medical devices/systems to optimize findability and usability of information

  • Recognized expert on how to write, organize, and present information in paper and digital form, including on devices

  • Organizes information by translating user behavior into information structure and elements

  • Produces workflow diagrams, use scenarios and storyboards

  • Develops style guidance and/or templates for organization of information

  • Applies application specialist knowledge (e.g., subject matter expert on device use from a user perspective) to design

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

  • Provides editorial/writing support and/or review in a variety of contexts including, but not limited to:

  • Supporting R&D, Clinical, Marketing, and other staff regarding information architecture considerations

  • Supporting the definition and development of system software and hardware user interface design(s)

  • Supporting the definition, design and writing of product labeling and training

  • Developing graphic representations of concepts, procedures, and other information for end users

  • Contributes to user interface designs by providing guidance, ideas, and review to UX designers and Human Factors peers

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

  • Ensures that human factors engineering documents follow good information architecture principles

  • In collaboration with Human Factors Engineers, identifies user needs/requirements, especially with respect to findability and usability of information from a user and customer needs perspective

  • Collaborates with development teams to optimize designs in consideration of information findability and usability, and where appropriate participates in identification, analysis, and evaluation of use-related risk and development of risk controls

  • Assists planning and conducting human factors analyses, unstructured testing, and structured usability studies. This may involve collaboration with Human Factors Engineers or executing studies and/or performing data collection and analysis, as well as writing study reports. It may also include recruiting usability study participants and/or managing related processes.

  • Contributes to the design development process by participating in design review meetings, reviewing and contributing to design inputs, and risk analyses

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

  • Assists with review, completion, and accuracy of documents produced by human factors engineering activities

  • Responsible for review of HFE assessments included in regulatory documents submitted to the FDA (or other regulatory bodies)

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

  • Responsible for keeping current on new developments in information architecture as it relates to human factors engineering and application management

  • Normally receives general work instructions on routine work, detailed instructions on new projects or assignments.

  • 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.

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

EDUCATION :

  • Bachelor’s Degree required; Advanced Degree desirable.

  • Degree in English or Technical Communications related field preferred

EXPERIENCE AND REQUIRED SKILLS:

  • 5 – 8 years’ medical device development experience; or a Master’s degree with 3 years’ experience; or a PhD without experience; or equivalent directly related work experience.

  • Minimum of 5 years writing documentation/screen content.

  • Demonstrated skills and experience in an editorial/writing and/or information architecture related role in new product development

  • Ability to observe and document behavioral research

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

  • Ability to work independently with a low level of supervision

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

  • Prior experience with human factors analyses and designing and executing usability studies desired, but not required

  • Familiarity with relevant quality regulations (21 CFR Part 820.30), and interest/ability to become familiar with relevant human factors/usability engineering standards (e.g., IEC 62366-1, ANSI HE75), and FDA guidance

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

  • Highly proficient in Microsoft Word and PowerPoint; other desktop publishing application experience a plus

  • Proficient with graphic design applications (e.g., Adobe Illustrator and/or Adobe Photoshop or similar)

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