JVT Advisors

Senior Human Factors Engineer

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Location: Lawrence, Massachusetts 01843
Employment Type: Contract

Job Description

Key Responsibilities:

  • Serving as a patient / customer advocate in helping realize the vision for delivering game-changing products that are safe & effective, easy to use, not prone to use error, and provide user satisfaction; ultimately supporting our 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
  • Contributing to user interface designs by providing heuristic design guidance, ideas, and feedback to project teams
  • Leading documentation review and development, including: risk analyses, user/environment profiles, task analyses, use specifications and HFE 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
  • 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
  • Detailed 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.)
  • Approximately 20-25% travel is expected of this position (all expenses covered)

 

Your Skillset

  • 5+ years’ experience in Human Factors / Usability engineering, and/or product design, development, or testing; experience with class II medical device products is preferred
  • Ability to communicate and present effectively, and 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.
  • 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
  • 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.
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Zack Lisien

Technical Recruiter

Zack uses traditional and digital resources to keep our talent pool brimming with highly skilled and qualified technology innovators searching for opportunities.

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