Human Factors Engineer
Company: NxStage Medical, Inc.
Posted on: January 5, 2022
ABOUT US IN 2022:
NxStage Medical, a Fresenius Company is on a mission to transform
renal care. To do that, we continually seek the best-of-the-best to
expand and improve our team of dedicated, innovative professionals.
If you share our mission and are committed to improving the lives
of renal patients, then we invite you to explore our career
In 2022 we are adding 70+ new roles to the NxStage family!!!
We are seeking professionals who want to bring their talents to a
Medical Device Organization that works directly with the patient,
at NxStage you Make A Difference You Can See!!!
As a Human Factors Engineer at NxStage, you will play a key role in
the design, development, use testing, documentation, and launch of
NxStage Medical's flagship products. You will play an integral part
in activities for new product development programs and drive
usability improvements for current products, collaborating with a
diverse team of engineers and working in a dynamic, fast-paced
environment. You will assist the Director of Human Factors to
support on-going business needs. NxStage products integrate
mechanical, electrical, software, and fluidic elements, and include
interactions with both wet and dry disposables components.
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
EDUCATION AND REQUIRED CREDENTIALS:
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 SKILLS :
Minimum 0 - 4 years of related experience.
Strong interpersonal skills with the ability to communicate with
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
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual
Fresenius Medical Care North America maintains a drug-free
workplace in accordance with applicable federal and state laws.
Keywords: NxStage Medical, Inc., Lawrence , Human Factors Engineer, Engineering , Lawrence, Massachusetts
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