Research Scientist R D

Experience

ZSFab Inc. Waltham, MA

Research Scientist Jan. 2022 - Present

R&D of an implantable spinal cage from concept to market

- Led the design of an FDA-compliant Class II implantable spinal cage and corresponding surgical instruments using SolidWorks.

- Collected and analyzed surgeon feedback and OR observations to translate clinical needs into precise engineering requirements.

- Conduct worst-case analysis and developed mechanical testing protocols per ASTM standards.

- Collaborated cross-functionally with regulatory, quality, and manufacturing teams to drive products from concept to market. Management of the FDA clearance process for a new 3D-printing pipeline

- Designed biocompatibility, packaging, and sterilization verifications to comply with FDA and NMPA requirements.

- Performed predicate device justifications for regulatory submissions.

- Analyzed and compiled verification reports, preparing 510(k) submission files using eSTAR. Optimization and size expansion of exsiting medical devices

- Optimized design features to meet different market needs while minimizing the risk of worst-case scenarios.

- Performed Finite Element Analysis (FEA) using Abaqus ensuring compliance with ASTM F2077.

- Led the redesign of corresponding instruments and analyzed reprocessing processes to ensure compatibility and functionality.

- Prepared detailed mechanical performance analyses to support a Special 510(k) submission. Establishment of the quality system in alignment with QSR 21 CFR Part 820

- Developed the documentation structure for the Quality Manual, Quality Procedure, and Design Control.

- Collaborated with quality engineers to optimize and maintain the quality system.

- Conducted letter-to-file analysis to assess and document the impact of qualified design changes, ensuring regulatory compliance. Orthopaedic & Developmental Biomechanics Lab, Boston University Boston, MA Research Assistant Sep. 2015 - Jan. 2022

Biomechanical modeling and analysis of spinal tissues and scaffolds

- Led the first-ever study of mechanical properties that integrates intervertebral discs and human vertebral endplates (VEP).

- Designed and conducted a four-point bend test using Instron to evaluate VEP mechanical properties through fracture analysis.

- Improved the vertebral Finite Element (FE) model accuracy by 20% to 95% using Digital Volume Correlation (DVC).

- Designed 3D-printed bio-ceramic scaffolds with diverse structures using SolidWorks and uniaxial compression testing. Yuanqiao Wu

Phone: 847-***-****

Email: *******@*****.***

Address: 70 Hope Ave, Apt 305

Waltham, MA 02453

Research Scientist with extensive experience in applying rigorous methodologies and interdisciplinary expertise to solve biomechanical challenges. Highly skilled in problem-solving and self-directed learning. Successfully led multiple projects from early-stage design to commercialization of FDA-approved Class II medical devices. Skills

Technical: Full-cycle FDA product design, Finite Element Analysis (FEA), Statistical Analysis, Image Processing Computer: Abaqus, JMP, MATLAB, ImageJ, Python, Java, Amira, ParaView, SolidWorks, AutoCAD, LaTex Lab: Mechanical testing (Instron), Imaging (Scanco, Zeiss Xradia), Cadaver Tissue Dissection, Wet Lab (BSL-2) Language: English (Bilingual), Mandarin (Native), Spanish (Elementary) Education

Ph.D. in Mechanical Engineering

Boston University (BU), Boston, MA GPA: 3.6/4

M.S. in Theoretical and Applied Mechanics

Northwestern University (NU), Evanston, IL GPA: 3.8/4 B.S. in Engineering Mechanics

China University of Mining and Technology (CUMTB), Beijing GPA: 86.4/100

• Wiley Top Cited Artical 2021-2022

• The USPTO Basic Patent Training

• Distingushed Mechanical Engineering fellowship

Certifications

Hobbies: Tennis USTA 3.5, experienced snowboarder, golf and heated yoga.

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