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Fresenius Medical Care North America Human Factors and Usability Engineer I in Lawrence, Massachusetts

*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 supportingNxStage’s goal of extremely low burden of care.

  • Supporting Product Management and Product Engineering personnel in establishingergonomic, 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 providingheuristic 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 inHuman 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 skillsindicating ability to work collaboratively with cross-functional partners

  • Excellent organizational skillsdemonstrating 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.

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