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Test Fixtures for ISO-10555 Test Methods

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Chunyi Chu

OVERVIEW

During my time in a regulated medical device test engineering environment, I designed and built custom test fixtures to support verification testing of intravascular catheters in accordance with ISO 10555 requirements. These fixtures were developed to address variability and operator dependence in existing test setups while also enabling lubricity testing to be brought in-house, reducing reliance on external testing. My individual contribution focused on translating ISO-based test intent into physical fixture designs that were compatible with existing lab equipment and capable of producing repeatable, quantitative data for flow rate and lubricity performance under simulated-use conditions. I iterated on fixture geometry, alignment features, loading conditions, and fluid routing to minimize external sources of variation and ensure results reflected true device performance rather than test artifacts. Bringing lubricity testing in-house reduced testing turnaround time and external costs while improving data accessibility and iteration speed during verification activities. The final designs improved repeatability, reduced operator-to-operator variability, and increased confidence in verification data used to demonstrate compliance with ISO 10555 performance requirements.

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SKILLS

Test fixture design aligned with ISO 10555 requirementsMechanical design for simulated-use testing in regulated environmentsDesign for repeatability, alignment, and measurement accuracyHands-on prototyping and iterative refinementRoot-cause thinking when addressing test variabilityTranslating ISO-based test requirements into physical hardwareCollaboration with engineering and quality teams
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Chunyi Chu

Mechanical Engineering Student

I am a Mechanical Engineering undergraduate with hands-on experience in regulated medical device development, test engineering, and design verification. I am especially drawn to hands-on engineering work that involves building, testing, and refining systems in environments where precision and reliability are critical.

My interest in engineering started early. In middle school, I began building and repairing computers — diagnosing hardware failures, swapping components, and learning how systems interact at both a physical and logical level. That curiosity naturally expanded into a broader interest in how complex systems are designed, tested, and improved.

Outside of academics and work, I am a car enthusiast who enjoys understanding vehicles beyond the surface level  from performance engineering to mechanical design decisions. This hands-on mindset carries into my engineering work: I enjoy building things, breaking them, understanding why they fail, and making them better. Looking ahead, I want to continue developing my skills within the biomedical device industry while exploring opportunities to apply engineering principles in the automotive space as well.

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