Kendra Chan
Biomedical Engineer for Medical Devices and Implants at dsm-firmenich | Driven to Better Healthcare for All & Empower the Youth of Our Generation
- Role
- Engineer Naturals Materials R & d at dsm-firmenich
- Location
- Sunnyvale, CA, US
- LinkedIn followers
- 500 followers
Experience
Engineer Naturals Materials R & d
Sep 2023 — Present · Exton, PA, US
Work extensively with calcium phosphate cements (CPC), bioactive glass, xenograft & collagen processing & products • Design & develop mechanical components using CREO for bone graft products, including 3D CAD modeling, prototyping, tolerance stack-ups, and testing• Lead cross-functional team to develop advanced synthetic bone graft preforms• Perform mechanical & analytical testing on biomaterials orthopedic devices to meet project specifications using statistical (Minitab) and FEA methods to validate performance• Create/execute V&V with confidence/reliability test plans to verify product performance • Lead design of experiments & testing per ISO and ASTM standards to quantify design requirements for regulatory submissions • Collaborate with quality, manufacturing, clinical, & marketing/commercial teams to define design inputs, supplier/process validations, biocompatibility studies, manufacturing design transfers• Create design history files, device master records, risk management plans & analysis (FMEA/PFMEA), DTM, and V&V protocols, to ensure compliance with FDA
Education
Drexel University School of Biomedical Engineering, Science and Health Systems
Master of Science in Biomedical Engineering, Biomechanics & Neuroengineering
Drexel University School of Biomedical Engineering, Science and Health Systems
Bachelor of Science in Biomedical Engineering , Biomechanic & Neuroengineering
2018 — 2023
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