• FRESENIUS
  • $116,070.00 -174,640.00/year*
  • Pittsfield , MA
  • Engineering
  • Full-Time
  • 555 West St

Position Specific Details

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

Position Summary:

As aHuman Factors and Usability Engineer II at NxStage, you will play a key role inthe design, development, use testing, documentation, and launch of NxStageMedical s flagship products. You will takepart in Human Factors & Usability Engineering activities for new productdevelopment programs and contribute to usability improvements for currentproducts (sustaining activities), collaborating with a diverse team of engineersand working in a dynamic, fast-paced environment. NxStage products integrate mechanical,electrical, software, and fluidic elements, and include interactions with bothwet and dry disposables components.

Key Responsibilities:

Servingas a patient / customer advocate in helping NxStage realize its vision fordelivering game-changing products that are safe & effective, easy to use,not prone to use error, and provide user satisfaction; ultimately supportingNxStage s goal of extremely low burden of care.

Supporting Product Management and ProductEngineering personnel in establishing ergonomic, human factors (HF), and usability-relatedrequirements for new products and product line extensions.

Supportingethnographic research, usability testing, individual interviews, and groupinterviews

Analyzingquantitative and qualitative data to inform design decisions and risk analyses

Contributingto user interface designs by providing heuristic design guidance, ideas, andfeedback to project teams.

Supportingdocumentation review and development, including but not limited to riskanalyses, user/environment profiles, task analyses, use specifications andHuman Factors Engineering reports to support regulatory filings

Drafting uFMEAs; collaborating with Systems Engineering inidentifying intended users and use environments, as well as potentialuse-related hazards; determine product use cases and identify critical usertasks

Analyzing complaints from on-market productsfor usability-related issues.

Flexibility with a range of productinterfaces from software GUIs, hardware/fluid connectors to workstations

Representing the Human Factors/UsabilityEngineering function on core teams for small to medium sized projects.

Collaboratingwith internal & external parties in planning, structuring, recruiting for,and executing formative and summative usability evaluations.

Working knowledge of the implementation of all relevantHF & usability-related standards and guidance documents (ANSI/AAMI/ISO14971, 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.

Qualifications

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.
  • Education &Qualifications:

    BSin a relevant Engineering discipline (or equivalent in a technical/scientificfield); MS is a plus.

    3+years experience in Human Factors / Usability engineering with a BS or 2+ yearsexperience with a MS; and/or product design, development, or testing;experience with class II medical device products is preferred.

    Requirements:

    Abilityto communicate and present effectively.

    Abilityto interface with customers in a highly professional manner.

    Excellenttechnical communication skills and attention to detail, including creating andediting technical research, analyses, protocols, and reports.

    Abilityto analyze and synthesize large quantities of information into usablecommunications.

    Abilityto prioritize and multi-task in a fast-paced, collaborative work environment.

    Basicunderstanding of system, electrical, and mechanical design, as well as softwareintegration.

    Priorexperience with complex electro-mechanical systems preferred, especiallysystems having fluidic and/or disposable components is a bonus.

    Experiencesupporting: formative and summative usability evaluations (structuring,recruiting for, conducting, and reporting on), especially involving class II orIII medical devices.

    Experienceworking with third-party service providers and external certificationlaboratories is a bonus.

    Workingexperience with medical device design and development processes that conform tostandards including: ISO 9000, ISO13485, IEC 62304, IEC 60601, IEC 62366, and ISO 14971.


    Associated topics: bsee, cellular, circuit, dsp, electrician, hardware, renewable, rf, schema, transmission

    * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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