SUMMARY:

• Over 10 years experience software and system development in IVD and medical devices.
• In - depth engineering knowledge and discipline in design and development of system and software.
• Design Control and System validation and verification for IVD and Medical Devices.
• Skilled in object-oriented design and programming, UML, and application of design patterns.
• Extensive experience in using algorithms to address diagnostic problems. Genomic Workflow, LIMS.
• Next Generation Sequencing and Analysis and Interpretation of Clinic or Oncology Applications.
• Dedicated, determined, and motivated team player and quick learner. Excellent collaboration and communications skills.

PROFESSIONAL EXPERIENCE:

Confidential, San Diego, CA

Staff Design Compliance Engineer

Responsibilities:

• Design, implementation, configuration, integrations of Pipelines, Workflow, BigData and LIMS; machine learning for NGSS Clinic Diagnostics Systems. Variants Data source and contents curation based on big date and machine learning platform, Variant Results classification, interpretations and reporting. Public and private Cancer Genomics database integrations, Client Service and physician portals Integrations.
• NGS System Integration, including the Sample Accession, Sample Preparation and Tracking, Scheduling, Integration with Pipelines for Primary, Secondary and Tertiary Data Analysis. Quality Monitoring and Control for Clinical Use of NGS workflows.
• Design Compliance with FDA (21 CFR Part 11 and 820), ISO (13485 and 14971), and IEC (62304 and IEC 62366). CAP Accreditation, CLIA s. Developing IQ,OQ,PQ processes and procedures for Clinic use of NGS System. Design and execute Verification and Validation Protocols, Scripts for IQ,OQ,PQ Workflows. Exam and review objective evidences, control and approval of Design Changes, V&V results and reports.
• System Quality Assurance for Compliance of Regulator Standards for System Design V&V. Root cause analysis of system problems. . Fault Tree and Hazard analysis of Sequencing Instrument and diagnostic workflow, Design Control and Agile developments. Develop System risks mitigation, write and execute protocols, analyzes data, and document results. Integration of Sequencing Quality LIMS Systems.

Confidential, South San Francisco, CA

Staff Design Compliance Engineer

Responsibilities:

• Products definition, Customer and System Specification Requirements developments, review and approve. Design History (DHF) structure and deliverables definition. Processes and procedures development, regulatory compliance, SOPs, working instructions authoring.
• System Architecture, Design, Implementation, Integration and Configuration of NGS Workflow and LIMS for Clinic Diagnostic Systems. NGS BPM and data analysis pipelines design and modeling and implementations. System Integration based on ESB and iPaaS. LIMS development and integrations with public database based with relation and no relation database.
• Design Compliance with FDA (21 CFR Part 11 and 820), ISO (13485 and 14971), and IEC (62304 and IEC 62366). CAP Accreditation, CLIA s. Fault Tree and Hazard analysis of Sequencing Instrument and diagnostic workflow, Mitigations, Design Control and Agile developments.
• Design NGS diagnostic system Verification and Validation (V&V), including the Sample Accession, Sample Prepare Tracking, Scheduling, Integration with Pipelines for Primary, Secondary and Tertiary Data Analysis. Monitoring Quality and Variants Databases. Integration with Client Service and Results interpretation and Report.
• Developing and executing of verification and validation protocols and review objective evidence for inclusion in V&V reports. Interface with FDA and other regularly bodies to ensure the Compliance.
• Feasibility and integration study and review, dFMEA, pFMEA, uFMEA, Fault Tree Hazard analysis of System, Sequencing Instrument and diagnostic software, and sequencing workflow IQ, OQ,PQ.

Confidential, Mountain View, CA

Software, Lead/Manager

Responsibilities:

• Managing System and Clinic Application software team and developing software for NGS based clinic applications. The Agile and XP software processes, JIRA, SCRUM.
• Work with external and internal software partners to enhance existing algorithms, modify and develop new open source bioinformatics algorithms for cutting edge NGS platforms, across a range of applications.
• Develop Database Centric LIMS applications to interface with library and sequencing Workflows.
• Design, implementation and integration Business Process Management (BPM) for NGS workflow, include, MES integration, PAT, SCADA, Sequencing pipeline control, imagine registration, basecall, mapping and sequencing assembly, variants call, classification an integrations.
• Feasibility, Fault Tree and Hazard analysis of Sequencing Instrument and diagnostic workflow, Design Control and Agile developments.

Confidential, Redwood Shore, CA

Sr. System Engineer

Responsibilities:

• System Framework development of Oracle ADF Fusion Applications of Oracle technology stack, include WebCenter, Enterprise Manager, SOA Suit (BPEL, Rules Engine, BAM, Composer, Human workflow) and Oracle DB.
• Warroom Environments for Oracle Fusion Enterprise Applications System Triages, integrations verification and validation of CRM, FSCM HCM.
• Apps Building and Implementation. Design and implement Use Cases based on Oracle ADF development pattern with JDeveloper and Fusion Middleware.
• Develop Unit Test framework for Fusion Middleware base on JUnit and JFC Unit, abbot, Selenium.

Confidential

Sr. System Development

Responsibilities:

• Design, implementation, integration of CK System, include Machine Control, Imagine process and Medical LIMS. Feasibility, Fault Tree and Hazard analysis of CK System.
• Lead system integration, root cause analysis of system problems. Develop System mitigation, write and execute protocols, analyzes data, and document results. Integration of CK Patient Customer Hospital CDMS Systems.
• Interface RD and Marketing and PM, Tractability implementation and risk analysis of CK. Responsible for the planning, system control and targeting locating algorithms.
• Design Control and System Development, verification and validation (V&V) activities for FDA and Regulatory Compliance affairs. Development and implementation of Corrective Action and Preventive Action (CAPA). Design history and compliance analysis, produce and generate the necessary results and documentations for multiple of FDA 510k applications and approvals.

Confidential, Foster City, CA

Sr. Software Engineer

Responsibilities:

• Design, development and testing of SDS software on 7900 HT real-time PCR machine for genotype and gene expression, resulting in the successful implementation of FDA 21 CFR part 11compliant capability. Responsible for many functional designs, implementation and testing utilizing Swing GUI, XML (JAXP, JAXB) message over JMS, automatic control with C++, JDBC in database layer, Application server JBoss and Oracle 9i at the backend.
• Design, development and testing of high throughput genotype (SNP Manager), gene expression (RQ Manager) and their integration with LIMS Systems. Participated in validation of integration of software, chemistry, and instrumentation. Responsibility includes the implementation of Swing GUI, client side algorithms, JDBC, FDA 21 CFR part 11 capabilities.
• Design, implementation and execution of Industry Best Practice and XP Programming Process. Participated in implementation of ANT-based building and continuous integration (CI) processes. Implemented unit test cases under the JUnit and JFCUnit frameworks.

Sr. Software Engineer

Confidential

Responsibilities:

• Designed and implemented distributed Primer Express software based on the Request and Response framework over JMS. Implemented XML messages and client and server side XML parse and persistence. Participated in J2EE component integration with PCR Primer Express software.
• Designed and implemented stand-alone PCR Primer Express software. Implemented the algorithms and GUI and integrated them with the Presentation Framework.

Sr. Software Engineer

Confidential

Responsibilities:

• Development, implementation and debugging of HIV and HLA Genotype software and diagnostic kit, resulting in 510(k) marketing clearance. HIV virus Sequences and base-calls signals processing. Sequence assembling. Drug logic development and clinic applications.
• Functional integration and validation and verification resulted in FDA 510k approval. Designed and implemented auto scripting tools for HIV Genotype software. Implemented the framework and test scripts.
• Software configuration and life cycles management. Capability, Maturity Model (CMM) management.