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Chunyi Chu

Mechanical Engineering Student

Boston, MA

ABOUT ME

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.

PROJECTS
CONTACT
RESUME
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Corrective and Preventive Action (CAPA) investigations

I supported a Corrective and Preventive Action (CAPA) investigation within a regulated medical device quality system, addressing a product performance issue that required structured root-cause analysis and cross-functional coordination. The...

Risk-based decision makingCross-functional collaborationTechnical documentation and traceabilityRoot cause analysis and structured problem-solvingAnalyzing test data to support engineering decisionsUnderstanding of quality systems and regulatory expectations
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Test Fixtures for ISO-10555 Test Methods

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...

Hands-on prototyping and iterative refinementCollaboration with engineering and quality teamsRoot-cause thinking when addressing test variabilityTest fixture design aligned with ISO 10555 requirementsDesign for repeatability, alignment, and measurement accuracyTranslating ISO-based test requirements into physical hardwareMechanical design for simulated-use testing in regulated environments