Medical Device Project Manager
Resume:
Yuan Xu
*** ****** **** ****, **** NC *****
******@*****.***
OBJECTIVE
• Position of responsibility in R&D for software and application development. Responsible for all activities related to the design, development, and implementation of organizational information systems and software applications
STRENGTHS
• Strong knowledge integrated from Regulatory, Quality and Development for Software and hardware on medical device.
• Excellent Project Management skills and experience with product development from product Conception through product launch.
• Strong leadership skills for staff motivation, conflict management, communication, empowerment, team building, and leading by example with integrity.
• Hands-on experience in all aspects of Software/System Development Life Cycle and Medical device.
• Hands-on experience in Regulatory, Quality of Software/System for Medical Device.
• 9+ years of hands-on experience with FDA Compliance and Quality Assurance activities for IVD diagnostic reagents, instruments and software including Design Control, Risk Management, Manufacturing Process, CAPA, Complaint Handling, Clinical activities, FDA 510(k) submissions and FDA Audits.
• Supervisory experience organizing people and budget to accomplish company objectives effectively and efficiently.
MAJOR ACHIEVEMENTS
• Successfully launched over 20 medical device projects. Responsible for creating design control documents including but not limited to Design and Development planning, Requirements, Design Specification, Verification and Validation, Risk analysis, Requirement Trace Matrix to all testing, Design Transfer to Manufacture, Preparing FDA submission) and assuring compliance with FDA regulations and voluntary standards while meeting aggressive timelines.
• Developed and implemented a compliant Design Control system which passed repeated internal and external audits.
• Key team member for the implementation of electronic Document Management system.
• Assisted with 510(k) and obtained FDA clearance for novel IVD using NMR as a detection method.
AREAS OF EXPERTISE
RAC (Regulatory Affairs Certification) CSQE (ASQ Certified Software Quality Engineer)
Design Control (21 CFR Part 820.30) FDA Quality System Regulations, 510(k)s, ISO standards, IVD Directives, cGMP, GPSV
CAPA, Complaints, Investigations, Root Cause Analysis Validation on Software, Systems, COTS, Assay and Analytical Performance
Manufacturing Process Validation, IQ, OQ, PQ Software Implementation Lifecycle (SILC)
Software Engineering Institute (SEI)
Capability Maturity Model Integration (CMMI)
Risk Analysis, ISO14971, Risk Management Internal and External Quality Audits
Bi-lingual (Chinese and English) IEC 60601, ISO 13485, ISO 14971, ISO 9001
Java, C++, Linux, Oracle Project Management
EXPERIENCE
LipoScience, Inc. (Raleigh, NC) (2006 – Present)
Class II, IVD company; it is the first company to commercialize a laboratory test performed using NMR as a detection method.
Director Software Engineering
Serve as member of leadership team, responsible for all software design, development and all levels of V&V testing and clinical studies for medical devices, and ensuring flawless preparation, execution and documentation in an efficient and timely manner. The tasks include, but are not limited to:
• Ensure that development projects and software deployments meet business requirements and goals, fulfill end-user requirements, and comply with all applicable security, privacy, and audit requirements and regulations
• Establish effective working relationships with business department s to understand business requirements and direction
• Apply knowledge of mortgage industry standards and practices to advance the automation of loan servicing and back office operations
• Ensure that information necessary for internal and external reporting is available, current, and accurate, and that tools for business intelligence and reporting meet business requirements
• Align the resource and planning of all R&D activities.
• Develop and maintain Master Schedule and budge.
• Ensure all design and testing are in compliance with the FDA regulation.
• Develop requirements, specification, plans and protocols for software validation, systems validation and assay performance validation.
• Lead the cross-functional team to conduct the product risk analysis.
• Create risk management plan, system risk analysis matrix and risk summary report.
• Manage the development and deployment of new applications, systems software, and/or enhancements to existing applications.
• Manage the customization, adaptation, and maintenance of commercial off the shelf software (COTS) to meet requirements.
• Define and enforce software development methods, practices, and tool sets as worldwide standards.
• Collaborate with Operations, Security / Quality Assurance/RA, Customer Support organizations to ensure application delivery to end users meets performance and quality expectations.
• Review and analyze existing applications' effectiveness and efficiency, and then develop strategies for improving these systems.
• Research and make recommendations on software products and services in support of procurement and development efforts.
BioMerieux Inc. (Durham, NC) (2003 – 2006)
BioMérieux is a multinational biotechnology company providing solutions in the field of in-vitro diagnostics.
Sr. Software Project Management
• Successfully launched 9 medical device projects over 2 years. Responsible for assuring that 9 development projects were in compliance with all regulatory and voluntary standards and Design Control procedures while meeting aggressive release schedules.
• Oversaw sub-contracted projects (STELLARA) for adherence with the applicable requirements, schedule, and contracts.
• Routinely interacted at all organizational levels with any group or functional area necessary to enhance and assure the quality of all products.
• Responsible for all phases of the Development and Maintenance Life Cycle of product, including project planning, requirements definition, design and implementation, verification and validation, design transfer, design changes, and risk management.
• Participated in root cause analysis for complaint investigations. Identified, recommended and implemented Corrective and Preventive Action (CAPA) to resolve quality issues.
• Performed project audits in accordance with internal audit procedure and compliance requirements.
• Facilitated Design Review, technical reviews, system and sub-component Risk Analysis.
• Reviewed and approved product requirements, design and development plans, design outputs, verification and validation plans, protocols and summary reports.
• Ensured that Design History File (DHF), Device Master Record (DMR), and product launch books are assembled and maintained in accordance with QSR, EU, ISO and internal procedural requirements.
• Assisted with CE Marking and assembled Technical Document File (TDF).
Sony Ericsson Inc. (Research Triangle Park, NC) (1999 – 2003)
Sr. Software Project Management
National Meteorological Center (Beijing, P.R.China) (1990 – 1995)
Lead Software Engineer & Project Manager
EDUCATION
M.S., Electrical and Computer Engineering, NCSU (Raleigh, NC) 1999
B.S., Atmospheric Science, Meteorological Institute (Beijing, P.R China) 1990
Bi-lingual- Fluent in Chinese and English
CERTIFICATIONS
Six Sigma (DFSS) 2005, 2013
Regulatory Affairs Certification (RAC) (Active 2010 -2016)
Certified Software Quality Engineer (CSQE) (Active 2006-2016)
Executive Leadership Development at UNC Kenan-Flagler Business School 2011
KARRASS' Effective Negotiating 2012
AFFILIATIONS
ASQ Active Member (2003-present)
AAMI Active Member (2006-presnt)
RAPS Active
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