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Sr Human Factors Design Eng / Usability Engineer

Larkfield, CA 95403

Posted: 10/26/2023 Employment Type: Contract Job Category: Data Sciences Job Number: 584419 Is job remote?: No Country: United States

Job Description


HM's Top Needs:
  1. Experienced in medical device usability regulatory standards and requirements. Knowledge of FDA Usability Engineering guidance document and regulatory body deliverables for Usability
  2. Experience with Risk documentation architecture, completed task analyses and inputting to UFMECA risk controls
  3. Experience conducting and reporting on Formative and Summative evaluations
 
Education Required: Bach Degree in relevant Engineering / Science or related discipline – If a Human Factors/Usability Engineering degree is a possibility that would be ideal.  Advanced degree desirable but not necessary

Years’ Experience Required:       5 years
 
A DAY IN THE LIFE:
  • Applies human performance principles, methodologies, and technologies to the design of human-machine systems and products.
  • Develops and implements research methodologies and statistical analysis plans to test and evaluate developmental prototypes used in all phases of products development and processes.
  • Designs and executes tests to simulate product use for the purposes of concept selection/refinement, requirements development, use-related risk identification and formal usability validation with intended users.
  • Interfaces with design engineers to establish system design, operating, and training requirements and to ensure optimized human-machine interfaces by providing Human Factors support, including identifying, planning, monitoring, and executing Human Factors tasks for projects.
  • Develops task analysis, use error analysis, human factors and usability-related requirements, generation of concepts (creation of physical models and prototypes), graphical (software) user interface design, usability testing, risk management, and post-launch outcomes analysis.
  • Identifies and analyzes technological problems or risks, performs theoretical human factors investigations, and develops and implements research and analysis plans.

 

KEY SKILLS & EXPERIENCE
  • Level 8 Degree in relevant Engineering / Science or related discipline.  Advanced degree desirable but not necessary
  • 5+ years relevant industrial experience in performing human factors engineering in medical device development.
  • You are experienced in medical device usability regulatory standards and requirements.
  • You are experienced in writing formative and summative usability test protocols and reports, and designing instructions for use (IFU) documents
  • You are experienced in moderating usability studies that have been used for regulatory submissions.
  • You have the ability to integrate creative skills with innovative problem-solving techniques to support development of design concepts.
  • You have experience completing field case research and case study observation with proven ability to apply findings into human interface requirements.
  • You are a dynamic team player, with a proven ability to integrate into and influence multidisciplinary teams.
  • You are a good communicator and have strong oral and written technical communication skills.
  • Travel expectation, up to 20% to Europe and United States
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