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Human Factors Engineer

Company: NxStage Medical, Inc.
Location: Lawrence
Posted on: January 5, 2022

Job Description:

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 opportunities.
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!!!

PURPOSE:
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 factors engineering.

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 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.

Keywords: NxStage Medical, Inc., Lawrence , Human Factors Engineer, Engineering , Lawrence, Massachusetts

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