- Human Factors Engineering for Class III medical devices
- Experience navigating complex regulations including FDA QSR, CFR 820, ISO13485, ISO14971, IEC62366 (Usability Testing), and EU Medical Device Regulations
- Previous use of Error Analysis
- Responsible for providing human factors engineering support to ensure the successful development of client's Neuromodulation devices and ongoing operational support
- Responsible for risk analysis activities including task analysis, use error analysis, and use related risk analysis
- Responsible for product design evaluation activities including simulated use testing, heuristic reviews, formative evaluations, summative validation, and analysis of post-market surveillance data
- 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.
- Identifies and analyzes technological problems or risks, performs theoretical human factors investigations, and develops and implements research and analysis plans.
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Sr. Human Factors Engineer - Minneapolis, United States - Redbock - an NES Fircroft company
Description
Sr. Human Factors Engineer (12 month contract // REMOTE, team based Minneapolis, MN):
All potential candidates should read through the following details of this job with care before making an application.
W2 ONLY - unable to work C2C/Sponsor
Team prefers a hybrid resource but will consider remote candidates
Top Skills:
Primary Responsibilities:
Description:
Required Knowledge and Experience:
Requires a Bachelor's Degree and minimum of 5, preferably upwards of 10 years, of relevant experience