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Human Factors and Usability Engineer I

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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.

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