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Human Factors & Usability Engineering Manager

Company: Sigma Inc
Location: Lawrence
Posted on: November 16, 2022

Job Description:

-15244 -Human Factors & Usability Engineering Manager, Lawrence, MA, 6 Months contract -
Sigma.Inc is currently looking for a -Human Factors & Usability Engineering Manager -to work onsite with our team located in Lawrence, MA. -

Note: -Candidates need to be local to Lawrence as they will be onsite 3-5 days a week depending on project needs. Covid vaccination required.

Description:
As the Manager, Human Factors Engineering 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 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.

    Education:


    • BS in a relevant Engineering discipline (or equivalent in a technical/scientific field); MS preferred.
    • 8+ years related experience in Human Factors / Usability Engineering and/or product design, development, or testing; experience with class II medical device products is preferred.
    • 3+ years supervisory or project/program management experience preferred
    • 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

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Keywords: Sigma Inc, Lawrence , Human Factors & Usability Engineering Manager, Executive , Lawrence, Massachusetts

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