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PURPOSE AND SCOPE:
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. 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 the Manager, Human Factors and Usability Engineeringat NxStage, you will play a key role in the design, development, use testing, documentation, and launch of NxStage Medical’s flagship products. You will lead Human Factors & Usability Engineering (HFUE) activities for new product development programs and drive usability improvements for current products, collaborating with a diverse team of engineers and working in a dynamic, fast-paced environment. You will assist the Director of Human Factors and Usability Engineering in identifying usability-related organizational needs and in establishing the internal capabilities and external relationships needed to support on-going business needs. NxStage products integrate mechanical, electrical, software, and fluidic elements, and include interactions with both wet and dry disposables components.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Advocate for the end user in helping NxStage realize its vision for delivering game-changing products that are safe & effective, easy to use, not prone to use error, and that entail an extremely low burden of care.
- Support Product Management and Product Engineering personnel in establishing Human Factors (HF) and Usability-related requirements for new products and product line extensions.
- Lead and support ethnographic research, usability testing, individual interviews, and group interviews, as well as other formative evaluation methodologies
- Analyze quantitative and qualitative data to inform design decisions and risk analyses
- Contribute to user interface designs by providing heuristic design guidance, ideas, and feedback to project teams
- Analyze complaints from on-market products for usability-related issues and provide UOUP compliance per IEC 62366-1
- Demonstrate flexibility with a range of product interfaces from software GUIs, hardware/fluid connectors to workstations
- Represent the Human Factors/Usability Engineering function on core teams for large sized projects
- Document intended users and use environments in Use Specifications
- Evaluate potential use errors and use-related hazards via drafting use scenarios and task analyses; Identify critical tasks and contribute to risk control measure identification/creation; leverage range of risk management methodologies including FTA, FMEA, and hazard analysis
- Author summary HFUE reports and other documentation needed to support regulatory filings.
- Assist management in ensuring that NxStage design, testing, documentation and regulatory submittal activities are fully compliant with and reflect best-practices with respect to 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.).
- Collaborate with internal & external parties in planning, structuring, recruiting for, and executing formative and summative usability evaluations.
- Identify HFUE related organizational needs; work with senior management to establish internal capabilities and external relationships needed to support on-going business needs.
- Mentor and develop HFUE team members
- Deliver and coach high quality specifications, design control and risk management deliverables
- Maintain schedule of HFUE activities across projects, deliver HFUE activities/documentation on time and manage team workload
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.
EXPERIENCE AND REQUIRED SKILLS:
- Subject-Matter Expertise (SME) understanding of medical device product design and regulatory processes.
- Excellent communications, writing, and presentation skills.
- 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
- Ability to work independently and resolve cross functional issues independently
- Detailed 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 in the application of best-practice product development methodologies, especially as they relate to the application of Human Factors and usability engineering principles.
- Experience leading: formative and summative usability evaluations (structuring, recruiting for, conducting, and reporting on), especially involving class II or III medical devices
- Expert level understanding with medical device design and development processes that conform to standards including: ISO 9000, ISO 13485, IEC 62304, IEC 60601, IEC 62366-1, IEC TR 62366-2, and ISO 14971.
- Experience working with third-party service providers and external certification laboratories is a bonus
- Travel: 15-25% (will fluctuate with project needs)
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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