Fei Z.
Innovative Implantable Devices R&D
- Role
- R & d Distinguished Engineer at Edwards Lifesciences
- Location
- Orange County, CA, US
- LinkedIn followers
- 500 followers
About Fei Z.
20+ years of RD experience in leading and supporting innovative implantable cardiovascular device development.• Strong technical expertise in the design, optimization, structural analysis, specification, rapid prototyping, testing, design verification/validation, manufacturing, supplier development/scale-up processing development/transfer.• Successful experience in technical project management. Trusted cross-functional team leader and thought partner capable of developing & managing multiple projects/work streams and driving key results in fast paced programs. • Subject Matter Expert in fatigue/reliability assessment, new technology assessment, and test strategy development. Authored technical summaries and journal papers outlining technical learnings and recommendations. Familiar with FDA/ISO Standards/guidance documents for device development.• Strong hands-on, self-motived, high-quality driven, excellent problem solving, diagnostic, collaboration, influencing, and technical written skills with 40+ peer reviewed journal publications.
Experience
R & d Distinguished Engineer
Apr 2004 — Present · Irvine, CA, US
Led and supported design drawing/specification, DV protocol/testing/report, risk assessment plan development of multiple new devices. Generated design control documents for regulatory submissions/responses. • Technical leader/project manager of Nitinol fatigue/design reliability assessment project from conceptualization, design iterations, validation of FEA modeling, and statistical methodology development, contributing to the approval of multiple new devices in EU and US (from early stage to commercial lunch).• Developed Nitinol device design reliability assessment strategy well received by FDA and received “Technical Publication of the Year Winner” of annual Edwards Lifesciences EMC Award (2020)”.• Technical leader/manager of projects to assess corrosion risk of implantable devices and to develop specification. Proactively identified key factors for risk mitigation, processing optimization and new supplier development strategy. • Established advanced material testing lab and maintain strong relationships with various internal teams in developing material specification/drawing, new test methods/fixtures, design validation protocols/reports, assessing advanced material characteristics, component functional performance, and supplier quality. • Lead an early-stage product development project to explore self-expandable, low-profile frame/stent from concept, design iteration, prototyping, and testing/performance evaluation stages.• Led the raw materials and finished components supplier development (quality assessment and optimization) to meet device (PASCAL) commercialization requirement. Generated device/component specifications. • Coach/Mentor junior engineers. Managed/supervised lab technicians. Interact with peers and regulatory agencies. Lead internal Nitinol technology development council and contributed chapters to internal design guidance for Nitinol device development.
Education
Northeastern University, China
BS, Materials Sciences
Northeastern University, China
MS, Materials Sciences
Northeastern University, China
PhD, Materials Science
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