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Quality Engineers are responsible for determining and mitigating risk to the end user from the product/procedure. Includes working with R&D on specification setting and design verification (DV) testing as well as managing documentation related to process, design and use failures (FMEAs) that could occur. The role can also involve investigations into these failures and implementing changes to prevent them from occurring in the future. (PRAs/CAPAs)
Technical Skills Needed:
Stats
Design work/CAD drawings (more about understanding designs of others than doing it yourself)
Root cause analysis
Collaborate with
R&D
Manufacturing
Important Skillsets: Critical thinking/problem solving, teamwork/collaborative ability, decisiveness, communication and presentation skills
Helpful Experiences: BME Design Fellows, Design Health
Example Project: "One project I worked on was developing a new measurement method for the shaft of a next gen product. The design involved a rounded edge that was not flat/was difficult to fix into position to measure so I developed a fixture and Keyence method that would automatically measure the required dimensions to improve the process for both R&D and manufacturing process development. I tested the method and ran several Gage R&R studies and COV (components of variation) studies to best control the measurements and be confident in their repeatability and reproducibility."
Piece of Advice from a Duke BME Graduate: "You learn a lot on the job, so starting out you can’t expect to know nearly as much as you want to. But it gets easier to learn a new role/team quickly if you ask more questions and immerse yourself fully in the team"
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