Chunyi Chu

Mechanical Engineering Student

Boston, MA

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WELCOME!

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.

Corrective and Preventive Action (CAPA) investigations

Scope / Challenge: Supported a Corrective and Preventive Action (CAPA) investigation within a regulated medical device quality system to address a product performance issue. The goal was to identify root causes, support effective corrective actions, and maintain full documentation and traceability t...

Root cause analysis and structured problem-solvingAnalyzing test data to support engineering decisionsUnderstanding of quality systems and regulatory expectationsCross-functional collaborationTechnical documentation and traceabilityRisk-based decision making

Test Fixtures for ISO-10555 Test Methods

ISO 10555 Catheter Verification Test Fixtures: Scope / Challenge Designed and built custom test fixtures to support verification testing of intravascular catheters in accordance with ISO 10555 requirements. The project focused on reducing operator dependence, improving repeatability, and bringing l...

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