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Form of workNxStage 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.
As a Human Factors and Usability Engineer III 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.
- Leading and supporting ethnographic research, usability testing, individual interviews, and group interviews
- Analyzing quantitative and qualitative data to inform design decisions and risk analyses
- Leading heuristic design evaluations, idea generation, and feedback to project teams with the goal of contributing to user interface designs
- Leading and supporting documentation review and development to support regulatory filings, including but not limited to: risk analyses, user/environment profiles, task analyses, use specifications and user interface specifications and Human Factors Engineering reports
- Drafting uFMEAs and Use Error Analyses; identifying potential use-related hazards and determine product use scenarios and critical user tasks
- Analyzing complaints from on-market products for usability-related issues.
- Working flexibly 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 medium sized projects
- Mentoring and coaching junior engineers and teams regarding Human Factors processes and principles
- Collaborating with internal & external parties in planning, structuring, recruiting for, and executing formative and summative usability evaluations
- Implementing all relevant HF & usability-related standards and guidance documents (ANSI/AAMI/ISO 14971, AAMI/ANSI HE75, ANSI/AAMI/IEC 62366-1, IEC 60601-1-6, IEC 60601-1-8, FDA Guidances, etc.)
Physical Demands & 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.
Education & Qualifications:
- BS in a relevant Engineering discipline (or equivalent in a technical/scientific field); MS is a plus.
- 5+ years experience in Human Factors / Usability engineering with a BS or 4+ years experience with a MS or PhD
Requirements:
- Experience with product design, development, or testing in a regulated industry is a requirement (combination product or medical device experience with class II or III medical device products is preferred)
- Working knowledge and experience with device design and development processes that conform to standards, including: ISO 9000, ISO 13485, IEC 62304, IEC 60601, IEC 62366-1, and ISO 14971.
- 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 leading 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
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.
