Job ID 200006HG
Available Openings 1
Position Specific Information 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.
We are leveraging virtual technology to engage with you and keep us all safe while you explore a career with us. We will conduct all interviews virtually, to allow us to still connect about this job and proceed with our hiring process while practicing social distancing.
As a Human Factors and Usability Engineer II 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.
- 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
- Drafting uFMEAs; collaborating with Systems Engineering in identifying intended users and use environments, as well as potential use-related hazards; determine product use cases and identify critical user tasks
- 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
- Representing the Human Factors/Usability Engineering function on core teams for small to medium sized projects
- Collaborating with internal & external parties in planning, structuring, recruiting for, and executing formative and summative usability evaluations
- Working 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.)
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
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.
- Approximately 20-25% travel is expected of this position.
- BS in a relevant Engineering discipline (or equivalent in a technical/scientific field); MS is a plus
- 3+ years experience in Human Factors / Usability engineering with a BS or 2+ years experience with a MS; and/or product design, development, or testing; experience with class II medical device products is preferred
EXPERIENCE AND REQUIRED SKILLS:
- Ability to communicate and present effectively
- Ability to interface with customers in a highly professional manner
- Excellent technical communication skills and attention to detail, including creating and editing technical research, analyses, protocols, and reports
- Ability to analyze and synthesize large quantities of information into usable communications
- Ability to prioritize and multi-task in a fast-paced, collaborative work environment
- Basic understanding of system, electrical, and mechanical design, as well as software integration
- Prior experience with complex electro-mechanical systems preferred, especially systems having fluidic and/or disposable components is a bonus
- Experience supporting: formative and summative usability evaluations (structuring, recruiting for, conducting, and reporting on), especially involving class II or III medical devices
- Experience working with third-party service providers and external certification laboratories is a bonus
- Working experience with medical device design and development processes that conform to standards including: ISO 9000, ISO 13485, IEC 62304, IEC 60601, IEC 62366, and ISO 14971
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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