Sr. Human Factors and Usability Engineer
Company: Fresenius Kidney Care
Location: Lawrence
Posted on: May 24, 2023
Job Description:
Sr. Human Factors and Usability Engineer page is loaded Sr.
Human Factors and Usability Engineer Apply locations Lawrence, MA,
USA time type Full time posted on Posted 3 Days Ago job requisition
id R0092339 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 opportunities. As a Sr. Human Factors and
Usability 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 take part in Human
Factors & Usability Engineering activities for new product
development programs and contribute to usability improvements for
current products (sustaining activities), collaborating with a
diverse team of engineers and working in a dynamic, fast-paced
environment. NxStage products integrate mechanical, electrical,
software, and fluidic elements, and include interactions with both
wet and dry disposables components PRINCIPAL DUTIES AND
RESPONSIBILITIES:
- Serving as a patient / customer advocate in helping NxStage
realize its vision for delivering game-changing products that are
safe & effective, easy to use, not prone to use error, and provide
user satisfaction; ultimately supporting NxStage's goal of
extremely low burden of care
- Supporting Product Management and Product Engineering personnel
in establishing ergonomic, human factors (HF), and
usability-related requirements for new products and product line
extensions.
- Supporting ethnographic research, usability testing, individual
interviews, and group interviews
- Analyzing quantitative and qualitative data to inform design
decisions and risk analyses
- Contributing to user interface designs by providing heuristic
design guidance, ideas, and feedback to project teams
- Supporting documentation review and development, including but
not limited to risk analyses, user/environment profiles, task
analyses, use specifications and Human Factors Engineering reports
to support regulatory filings
- Drafting uFMEAs; collaborating with Systems Engineering in
identifying intended users and use environments, as well as
potential use-related hazards; determine product use cases and
identify critical user tasks
- Analyzing complaints from on-market products for
usability-related issues.
- Flexibility with a range of product interfaces from software
GUIs, hardware/fluid connectors to workstations
- Representing the Human Factors/Usability Engineering function
on core teams for small to medium sized projects
- Collaborating with internal & external parties in planning,
structuring, recruiting for, and executing formative and summative
usability evaluations
- Working knowledge of the implementation of all relevant HF &
usability-related standards and guidance documents (ANSI/AAMI/ISO
14971, AAMI/ANSI HE75, ANSI/AAMI/IEC 62366, IEC 60601, etc.)
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 :
- BS in a relevant Engineering discipline (or equivalent in a
technical/scientific field); MS is a plus EXPERIENCE AND REQUIRED
SKILLS:
- 5+ years experience in Human Factors / Usability engineering
with a BS or 3+ years experience with a MS; and/or product design,
development, or testing; experience with class II medical device
products is preferred
- Ability to communicate and present effectively
- Ability to interface with customers in a highly professional
manner
- Excellent technical communication skills and attention to
detail, including creating and editing technical research,
analyses, protocols, and reports
- Ability to analyze and synthesize large quantities of
information into usable communications
- Ability to prioritize and multi-task in a fast-paced,
collaborative work environment
- Basic understanding of system, electrical, and mechanical
design, as well as software integration
- Prior experience with complex electro-mechanical systems
preferred, especially systems having fluidic and/or disposable
components is a bonus
- Experience supporting: formative and summative usability
evaluations (structuring, recruiting for, conducting, and reporting
on), especially involving class II or III medical devices
- Experience working with third-party service providers and
external certification laboratories is a bonus
- Working experience with medical device design and development
processes that conform to standards including: ISO 9000, ISO 13485,
IEC 62304, IEC 60601, IEC 62366, and ISO 14971 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.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual
Orientation/Gender Identity Fresenius Medical Care North America
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Keywords: Fresenius Kidney Care, Lawrence , Sr. Human Factors and Usability Engineer, Engineering , Lawrence, Massachusetts
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