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Manager Medical Device

Chicago, Illinois, United States
January 30, 2018

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**** * ***** **** **** 847-***-****

Palatine, IL 60067 Cell 847-***-****

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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. 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.


■ 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


Genfare Division of SPX (SaaS, Cloud, Mobile, Web, UI), Elk Grove Village, Illinois 10/2017 – Present

Senior Program Manager (Engineering Development, Release Management, Implementation Management)

Plans, directs, and coordinates activities of projects with internal Engineering from concept to release.

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, and arrange assignment of project personnel

Prepares project reports for management and the clients (HW, SaaS, Mobil Apps, Cloud Data)

Rauland-Borg (Medical Device, Enterprise IT, Mobile, Web, API), Mount Prospect, Illinois 05/2010 – 09/2017

Director of Engineering Development / QA Validation (6/2015 - 9/2017)

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 (5/2010 - 6/2015)

Project/Program Management of all IT Servers, SW, HW, MFG Projects from Concept to field Deployment.

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

Haemonetics (Medical Device, IT, DB, Web, UI/UX, Enterprise Server), Rosemont, Illinois 06/2009 - 04/2010

Senior Software Engineering Manager, Server/Client Applications

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

Baxter Healthcare (Medical Device, Pharma, Embedded), Round Lake, Illinois 02/2002 - 05/2009

Engineering Project Manager (06/2006 - 05/2009) / Software Engineering Manager (02/2002 - 06/2006)

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).

MOTOROLA, Inc. (Telecom, Mobility), Schaumburg, Illinois 04/1995 - 11/2001

Senior Lead Software Engineer (04/1995-12/2000) / Section Engineering Manager (12/2000-11/2001)

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.

ABBOTT LABORATORIES (Medical Device), Abbott Park, Illinois 12/1989 - 04/1995

Software Quality Engineer (12/1989-05/1991) / Software Engineer (05/1991-04/1995)

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.

Tools and Programming Languages:

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.


Electrical and Computer Engineering, Bachelor of Science, August 1989. Ohio University, Athens, Ohio

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