SUMMARY:

• A goal oriented, dedicated and motivated Engineering Director and Project/Program Management Director with 25+ years of experience in all aspects of SDLC for Software, Hardware, IT projects development with extensive experience in Agile & waterfall methodology.
• Hands - on experience in Requirements definition for customer needs, Engineering SW & HW development, QA, V&V leadership, Build & Release planning, and Maintenance in waterfall or Agile Development Process.
• Comprehensive knowledge and experience of Medical Device, Education or Telecom development with proven record of accomplishment of projects completion, compliance, deployment with top quality and on-time delivery within defined budget.

AREAS OF EXPERTISE:

• Program / Project Management IT & SW/ HW Engineering Management QA, V&V Leader and Management
• Presentation to CEO and Leadership team IT, ITIL Development, Problem/Change/Operation/ update Management
• Supplier Audit / Management MFG Operation Management Outsource Management Change Management
• Roadmap and Strategy Planning Release & Deployment Management Resource planning and Management
• Vender and Outsourcing Management Corrective and preventative Action (CAPA) Issue Resolution/Management
• FDA 21 CFR Part II, GMP, CE, UL1069 Regulation Compliance Development Project & Product Risk Analysis
• System Architecture Definition SW Embedded, Servers Application, SQL DB, Mobility Apps Development
• System Integration Implementation Change impact analysis System Configuration Management SW Architect
• PCP SMT planning and prototyping HW & MFG Prototyping Development planning for Manufacturing
• Manufacturing Transfer Manufacturing Operations / Planning Design and Manufacturing for Six Sigma
• Quality Systems Audit Problem Solving / DMAIC Root Cause Analysis Critical Thinking FMEA Analysis
• Standard Operating Procedure (SOP) definition / implementation Work Instruction Definition / Implementation

TECHNICAL SKILLS:

Programming: C, C++, C#, .Net, XML, HTML, Java, Web, API, UI/UX, Real Time, Embedded Devices / programming, SQL Server, Windows Servers, Enterprise Architecture, Test Automation

SW Tools: Master Control, Jama, JIRA, Annotas, MS Project, ClearCase/ClearQuest, DOORs, Visio, Primavera.

PROFESSIONAL EXPERIENCE:

Confidential, Elk Grove Village, Illinois

Senior Program Manager

Responsibilities:

• Plans, directs, and coordinates activities of projects with internal Engineering from concept to deployment.
• Work with Customers and their Project Manager to full implementation of the HW and SW as designed
• Understand and define customer needs and response with project quotes from sales for implementation
• Establish work plan and staffing for the project, in Agile for SW, FW, Mobile Apps (Android and iOS)
• Prepares project reports for management and the clients (HW, SW, FW, SaaS, Mobil Apps, Cloud Data)

Confidential, Mount Prospect, Illinois

Director of Engineering Development / QA Validation

Responsibilities:

• Managing Engineering SW & HW development streams from Requirement to Quality Assurance.
• Requirements creation, Architecture, Development Reviews, testing Quality & Budget reporting
• Enterprise development for integrated system to connect 100’s of embedded devices to servers & Application
• Build / Release Management, QMS, Simulation, Automation, Performance & capacity Testing
• FDA, GMP, TUV, UL1069 Regulation Compliance, QSR audits, documentation and Testing

Director of PMO Project Management

Responsibilities:

• Project Management of all IT Servers/ Client, SW, HW, MFG Projects in Waterfall & Agile Development.
• Vendor Integration, Supplier audit, in coming quality assurance and Manufacturing Quality Reviews,
• Cost Estimation, Budget and Resource planning for all Engineering, IT, Manufacturing Changes.
• Multi-Projects / Programs management with Matrix Cross Functional Teams for Multi-million-dollar budget.
• Managing Vendor Integration Projects Through special API on on-going bases and supplier audit and quality
• Defining Short and Long Term Road map with CEO, CFO, VP of Marketing and VP of Engineering
• Defining Resource Management Plan and monitoring Resource Allocation usage for ~ 100 Engineer Dept

Confidential, Rosemont, Illinois

Senior Software Engineering Manager

Responsibilities:

• Senior Software Department Manager of three development teams and System Testing team 28 Engineers .
• Developed new Standard Operating Procedures for full life cycle SW Engineering Development.
• Special customer consulting projects estimation and development based on Customer needs.
• Development of five Medical Device Applications with regulatory FDA approval for Blood Banks.
• Managed projects, schedules, resources and budget within the Software Development Life Cycle.
• Worked Directly with many customers to improve Requirements, Deployment and Support Relations

Confidential, Round Lake, Illinois

Engineering Project Manager/Software Engineering Manager

Responsibilities:

• Managing a Cross Functional team of ~30 Engineers in a matrix organization (System, HW, SW, V&V)
• Hands-on developing Product Requirements (System and Subsystems) for SW Embedded Infusion Device
• Define Product Development Schedule and deliverables for FDA Compliance for 510 & CE Submission
• Define Controlled Launch and design transfer with Manufacturing Design Transfer to International Plant
• Managed outsourced Projects with external supplier (HCL India). Defined / monitored contract and budget.
• Managed teams in full Software Development Life Cycle Embedded/Windows server/PC application using (Hands-on Development in Windows Server 2003, .NET, C#, C, C++) in FDA regulated industry
• Managed a team for a full implementation of HW & SW program for Windows Server, Wireless Network.
• Managed Maintenance Engineering team for all Embedded infusion devices for Corrective Actions (CAPA).

Confidential, Schaumburg, Illinois

Senior Lead Software Engineer/ Section Engineering Manager

Responsibilities:

• Release Manager of Four software development teams for embedded software using (C, C++) on Solaris.
• Created roadmaps for release development and process improvement activities for clearer direction.
• Managed and analyzed new projects for staffing needs. Defined /Monitored Engineers assignments, progress
• Concurrently managed and tracked the development of multiple software projects; assessing the progress, risks and issues while ensuring effective integration to a final product.
• Completed all required project plans, documents and managed the project schedule using Primavera.
• As Senior Lead Engineer: I Led a team of eight engineers for software development Life Cycle releases
• Designed, coded and tested embedded real-time SW for eight releases using ('C', C++) on Solaris/ TCP/IP.
• Provided technical expertise for source code / configuration environment and build tools using ClearCase.
• Led the Change Control Board, managing the decisions for software fixes and improvements.
• Coordinated database SQL development and migration from INTERBASE to INFORMIX Database.
• Generated the Quality Assurance Plan for each box release and the quality matrix during the development.
• Improved all processes with the development team to reach SEI CMM level 3
• Evaluated the Software Quality Assurance Plans for other system elements.
• Managed the Global Development and Improvement databases and chaired the Change Control Board.

Confidential, Abbott Park, Illinois 5

Software Quality Engineer/ Software Engineer

Responsibilities:

• Designed, developed and maintained (C, C++, PL/M, Assembly) software for a blood diagnostics instrument.
• Designed, coded and maintained various hardware and firmware control subsystems including device drivers and interface library, (Barcode System, Robotic Pipetting System, Robotic Calibration System)
• Developed Function Spec and Detail Design Documents. Coded from Spec and Design the User Security module, Backup/Restore utility, Diagnostics utility, Report Management and System Configuration Utilities.
• Group leader of the test validation and verification team. The team is responsible for creating test plans and cases and for the execution of all test cases on the PRISM™ Blood test Medical device.
• Met all quality requirements for Safety to pass all the system regulations for medical device quality.
• Worked with the regulatory audit team to prepare all verification proofs for FDA submission.