Jason Li20724 Campania Ln, Northridge, CA 91326

Email: jli8@twc.com ~ Cell: 818-447-2630 ~ www.linkedin.com/in/jasonli8

SUMMARYResult-driven Reliability Engineer with technical leadership experience in system design, process improvement during various phases of product life cycle in Medical Device and other fast paced high-tech industries. Detail oriented problem solver, team player, and decisive bottom-line contributor. Proven track record of delivering results within the target time through budget, resource and time management.

Reliability Engineering Risk Management Engineering Specification Development Failure Analysis DFR & DFM, DOE Design and Process DevelopmentTest Development Product Qualification Process Validation and VerificationProject Management CAPA, RCM Data Analysis on Field Returns

TECHNICAL SKILLSIndustry Standard: QSRs, IEC, Mil-STD, ISO 13485, ISO 14971, ISO 11608, Telcordia. Database Management: SAP, DOORSSoftware: Microsoft Office, Minitab 17, Weibull++, XFMEA, ALTA, Relex

PROFESSIONAL EXPERIENCE

AMGEN, Thousand Oaks, CA 2015 – 2016Principal Engineer for Risk Management and Reliability Engineering (Contractor)Responsible for the risk and reliability engineering for injected drug delivery device. Conducted standard trace metrics for ISO 11608, IEC60601 and product specification compliance review. Implemented reliability program (ALT, Real time aging, ORT) for reusable electromechanical

auto-injector. Conducted and approved test protocol and test report for process validation including TMV /

IQ / OQ / PQ. Identified numerical noncompliance issues and proposed mitigation strategy during the

qualification phase, mitigating risk for potential submission delay.

MEDTRONIC INC., Northridge, CA 2003 – 2015Senior Principal Reliability Engineer and Project Lead, MiniMed DivisionResponsible for reliability of post market, New Product Introduction (NPI), Major CAPA task, design change qualification. Received Medtronic Star of Excellence Award in 2013 for successful implementation of reliability

program in product life cycle, Medtronic Star of Excellence Award 2015 for successful close CAPA for reducing annual keypad field complain issue by more than 60%.

Proposed and designed reliability analysis tool for field return analysis based on SAP database, enhancing sensitivity of detecting field reliability performance by 50% for new product launch or process / design changes; implemented in CAPA effectiveness monitor phase.

Implemented RCM and DRM practices throughout CAPA project (flow down requirements, use conditions, DFMA / DFR, capability and control). Achieved avoidable cost saving over $980K in the initial year of implementation.

Developed and validated qualification tool through feasibility studies and test method validation (TMV) for keypad application. Earned strong credibility and team work relationship with key suppliers for membrane switch design and process improvement initiative.

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Supported new product team to develop a reliability specification for infusion pump based on use conditions & voice of customer.

Designed and implemented an alternative keypad assembly, reducing annual field complaints by 60%.

Coordinated Lean-Sigma project and executed 6 projects related to field return reduction for product reliability and profit enhancement. o Implemented membrane switch circuit design (Keypad), saving $1.2M annually. o Designed and improved process for PCBA assembly, saving $200K annually.

Implemented HALT / HASS on new product development for early feedback on the weakest link, design margin. Result in effective implementation on design for reliability during design phase.

Drove FDA report change to achieve enhancement of clarity and accuracy in FDA MDR reporting. Initiated risk analysis on post market product and NPI through dFMEA, pFMEA and fault tree

analysis per ISO 14971. Key investigator for major critical failure on field return and accelerated life test (Electrical and

Mechanical). One of engineers presenting project (reliability analysis, CAPA tasks) to FDA auditors;

presentation was well received based on feedback from auditors during audit event in 2013. Developed effective qualification test method (TMV) for process optimization on plastic joints with

ultrasonic welding utilizing DOE, reducing field return associated with plastic stress crack by more than 70%.

Coordinated and drove cross functional team for product qualification and process verification and validation (V&V).

Trained engineering team and coached individuals for reliability analysis on field returns.

OPLINK COMMUNICATIONS INC., San Jose, CA 2000 - 2002Senior Staff Engineer and Project LeadInitiated DVT and Telcordia (GR468, GR1221, and GR1209) qualification for optical passive and active devices. Conducted product qualification and reliability tests in both system and component levels. Developed more efficient NPI process for product oversea transfer from pilot to mass production,

reducing qualification cycle by 20%. Initiated failure analysis on devices failed in reliability test or field return, improving future

design. Implemented highly accelerated life testing for FIT / MTBF analysis.

ADDITIONAL EXPERIENCEHEWLETT-PACKARD, MCD, Cupertino, CA Senior Hardware Engineer for laptop product Developed NPI qualification for mass storage device used in laptop application (hard disk drive

and other mass storage device), getting early feedback on product to avoid qualification delay.

EDUCATION

Ph.D. Mechanical Engineering, Purdue University, W. Lafayette, INM.S. Solid State Physics, Western Illinois University, Macomb, IL

B. S. Engineering Physics, Beijing University of Technology, Beijing, PRC

CERTIFICATIONS

Certificate of Reliability Engineer (CRE) authorized by ASQ 2015Certificate of Green Belt for Lean-Sigma authorized by Medtronic 2009

Certificate of Process Validation authorized by Medtronic 2014