Justin Wong
Mechanical Engineer at Pentax Medical
- Role
- Mechanical Engineer at PENTAX Medical
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
About Justin Wong
I’m a Mechanical Engineer with a passion for bridging innovation and implementation in…
Experience
Mechanical Engineer
Oct 2022 — Present · Redwood City, CA, US
Product Design & Development (R&D)- Conceived & executed innovative mechanical designs for next-generation medical devices, supporting preclinical & benchtop testing- Produced detailed engineering drawings with GD & T to ensure dimensional accuracy, manufacturability, & regulatory alignment- Developed a precision temperature data acquisition system to enhance verification & validation capabilities- Managed & mentored 3 junior engineers & 2 interns in the design & fabrication of test fixtures, ensuring consistency & adherence to design controls- Co-led animal testing for next-generation product, contributing to protocol development, equipment preparation, & on-site test execution- Designed a handheld press-fit assembly tool that reduced assembly time for the next-generation product by 30% & improved alignment accuracy during pilot builds- Supported the 510(k) submission for the latest 180 esophageal catheter by contributing design documentation, verification data, & test reports, including risk management documentation per ISO 14971.Manufacturing & Process Support- Contributed to the development of scalable, production-ready manufacturing processes through fixture design & procedural refinement, generating & implementing ECOs and MCOs- Partnered with cross-functional teams across R&D, quality, and manufacturing to enable smooth design transfer & improve design for manufacturability- Investigated field-returned products, performed Root Cause Analysis (RCA), & performed corrective actions to ensure performance met intended design specifications- Took initiative to develop an automated Nitinol inspection system, improving incoming raw material inspection & reducing inspection time by 20% and scrap yield by 20% through enhanced defect detection- Authored comprehensive technical documentation including validation and verification protocols, test reports, & controlled procedures aligned with internal QMS & regulatory requirements.
Education
University of California, Berkeley
Master of Science - MS
2021 — 2022
Ohlone College
Mechanical Engineering
2016 — 2019
University of California, Berkeley
Bachelor's degree
2019 — 2021
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