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Human Factors and Usability Engineer I

2 months ago

Lawrence, United States Fresenius Medical Care Full time
Position Summary:

As a Human Factors and Usability Engineer I 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.

Key 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
  • 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
  • Participating in cross-functional teams on new product development and manufacturing problem-solving efforts.
  • Supporting internal & external parties in planning, structuring, recruiting for, and executing formative and summative usability evaluations.
  • Beginning/limited 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.).
Education & Qualifications:
  • BS in a relevant Engineering discipline (or equivalent in a technical/scientific field); MS is a plus.
  • 0-3 years of experience in Human Factors / Usability engineering with a BS or 0-2 years of experience with a MS; and/or product design, development, or testing; experience with class II medical device products is preferred.


Requirements:
  • Ability to interface with customers in a highly professional manner.
  • Ability to communicate and present effectively.
  • Excellent technical communication skills and attention to detail, including creating and editing technical research, analyses, protocols, and reports.
  • Ability to prioritize and multi-task in a fast-paced, collaborative work environment.
  • Strong interpersonal skills indicating ability to work collaboratively with cross-functional partners
  • Excellent organizational skills demonstrating ability to manage time and following up on task progress/completion
  • Ability to analyze and synthesize large quantities of information into usable communications.
  • Basic understanding of system, electrical, and mechanical design, as well as software integration.
  • Some prior experience supporting: formative and summative usability evaluations (structuring, recruiting for, conducting, and reporting on).
  • Ability and eagerness to become familiar with relevant standards and quality regulations including: 21 CFR Part 820, IEC 60601, IEC 62366, FDA Guidance and ISO 14971.
  • Prior experience with complex electro-mechanical systems preferred, especially systems having fluidic and/or disposable components is a bonus.
  • Experience working with third-party service providers and external certification laboratories is a bonus.


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 maintains a drug-free workplace in accordance with applicable federal and state laws.