Sr Human Factors Design Eng / Usability Engineer
3850 Brickway Boulevard Larkfield, CA 95403 US
HM's Top Needs:
- Experienced in medical device usability regulatory standards and requirements. Knowledge of FDA Usability Engineering guidance document and regulatory body deliverables for Usability
- Experience with Risk documentation architecture, completed task analyses and inputting to UFMECA risk controls
- 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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