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Seeking a Senior Human Factor Engineer with roughly 5-10 years of experience in product development of medical products. This role will play a key part in the design, development, use testing, documentation, and launch of our products. You will take part in human factors & usability engineering activities for new product development programs and contribute to usability improvements for current products, collaborating with a diverse team of product development specialists and working in a dynamic, fast-paced environment.

In this role, we will ask you to:

  • Serve as a patient / customer advocate in helping us realize our vision for delivering game-changing products that are safe & effective, easy to use, not prone to use error, and provide user satisfaction.
  • Support product management and product engineering personnel in establishing ergonomic, human factors (HF), and usability-related requirements for new products and product line extensions.
  • Implement a variety of HFE research methods, such as task analysis, PCA, time/motion study, user preference studies, ethnographic research, heuristic analysis, root cause analysis and usability testing.
  • Analyze quantitative and qualitative data to in- form design decisions and risk analyses.
  • Contribute to user interface designs by providing heuristic design guidance, ideas, and feed- back to project teams.
  • Support 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.
  • Draft 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.
  • Analyze complaints from on-market products for usability-related issues.
  • Be flexible 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 small to large sized projects.
  • Collaborate with internal & external parties in planning, structuring, recruiting for, and executing formative and summative usability evaluations.
  • Have a 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, FDA, etc.).
  • Strive to balance strategic planning and tactical execution.
  • Work with team members to resolve conflicts among resources and between clients and engineering teams.
  • Remain apprised of the progress of certain projects, paying particular attention to any developing problems, and participate in major problem resolutions. Keep all privileged information private and confidential.
  • Be proficient in the latest version of SolidWorks CAD package, Microsoft, and Google products.
  • Travel as-needed (valid driver’s license and vehicle required).

Pay Range: 100-130K