Project Manager Software

BRIAN A. LISIEWSKI, P.E.

302-***-**** Cell

*****@*********.***

PROFILE OVERVIEW

. Leader of business, emerging technology, R&D, engineering, sales,

marketing, and financial operations.

. Simultaneous inventor and/or developer of medical devices, large-scale

software, and technical innovations across major pharmaceutical,

financial, manufacturing, production, and automotive industries.

. Liaise and interface with FDA and other governing bodies for new

technology approval.

. Core competencies include:

Research and development Financial operations

Regulatory compliance and validation Business management

Quality assurance and auditing Sales and market strategy

planning

Software engineering/system architect Product development/

introduction/delivery

Electrical engineering Staff management / training

design and delivery

Specifications writing Policy/procedure authoring

. Experienced in ISO 9001, ISO 13485, CFR 820, CIM (Computerized Integrated

Manufacturing), SPC (Statistical Process Control), and TQCM (Total

Quality Cost Management) working environments.

. Licensed Professional Engineer with NCEES Record Holder.

PROFESSIONAL EXPERIENCE

OTOVATION, LLC - KING OF PRUSSIA, PA 2005-PRESENT

A medical device company engaged in the design, manufacturing and

distribution of computer based audiometric equipment used in diagnosing

hearing loss and fitting patients with hearing aids.

Director of Engineering

Manage International product and software design teams located in the US,

Denmark, and England. Architect multiple software applications and lead

development efforts that control Otovation's audiometers in clinical and

diagnostic settings. All software products developed under .Net 4.0 and

written using C#. Manage product delivery in compliance with CFR 820 and

ISO 13485 regulations, and international quality standards. Engineering

point person for all FDA and ISO audits and product reviews.

. Co-author of company quality manual/procedures/processes compliant to

FDA CFR part 820 and ISO 13485.

. Designer/author of utility applications for device calibration written

in C# with wireless Bluetooth protocol.

. Creator of API level Software Development Kits for rapid programming

integration into current applications.

. Registered engineer for Otovation with both the FDA and International

Notified Bodies.

QUIESCENCE LLC - WILMINGTON, DE 2001-2005

Software/hardware applications design and implementation firm with

additional emerging technology device inventions requiring FDA approval.

Owner/Principal Software Designer

Primary visionary, business leader, and director of operations for

contracted deliverables. Oversaw sales and P&L operations. Project

leader, designer/implementer of software/hardware applications,

electronic design, and device invention for Fortune 100 corporate clients

as well as emerging technology requiring FDA approval. Led development,

product introduction, regulatory compliance, and validation initiatives

through to customer approval and quality assurance. Managed engineering

and programmer teams. Projects/initiatives included:

. Ultrasound system design/delivery to AstraZeneca and Pfizer for

major clinical trials. System met FDA regulations and validation

guidelines.

. Third party review auditor for Merck Sharp and Dome large-scale

software project. Ensured procedure compliance for software

development/validation, with FDA CFR 21-part11 auditing.

. Designer/developer of medical device measuring blood viscosity

across the entire sheer spectrum. Project included embedded device

firmware developed for the instrument, and applications for device

controller operating on host pc. Device submitted to FDA for 510k

approval.

. Implemented real time machine control application/porosity test

station for Johnson & Johnson ensuring medical packaging sterility

for the automated suture manufacturing line.

BRIAN A. LISIEWSKI

(Page 2)

. Designed Microsoft Pocket PC 2002 operating system field automation

application that managed OSHA compliance data for heavy industrial

equipment service/safety, and regulated information.

. Architected an account management database application solution for

major financial institution that monitored and dispensed incentives

to financial advisors globally.

DIGINEXUS, INC. - PHILADELPHIA, PA 2000-2001

Custom software engineering firm.

Director of Engineering Business Unit Manager Principal Software

Architect

Created and implemented an Industrial and Manufacturing Division vertical

within a high tech software company. Led design and production for a

custom software engineering firm providing full Software Development Life

Cycle software architecture for networked and enterprise software

systems. Directed financial operations with CEO reporting

responsibilities. Created and implemented sales and marketing for

Industrial and Manufacturing Division. Managed sales reps, business

analysts, software engineers, and tech writers.

Projects included:

. Designed a multi-tier enterprise system for a large pharmaceutical

company that related patients' medical records with claim forms

generated from a class action settlement.

. Developed a secure data protocol designed over UDP/TCP communication

layers operating on popular operating systems (Blackberry, Windows CE,

and Palm OS).

TESTWARE, INC. - BOYERTOWN, PA 1998-2000

A R&D and software/electrical engineering firm for commercially marketable

products serving the test and automation industries.

General Manager/Engineering Manager

Dual functionality for directing R&D operations, and developing

software/electrical engineering systems for commercially marketable

products relating to test and automation industries. Executed fiscal

planning. Responsible for operating budgets and corporate profitability.

Coordinated sales and marketing teams.

. Developed QA product for Johnson & Johnson fiber optics extrusion

operation, with subsequent FDA regulatory submission and ultimate

approval.

FORD MOTOR COMPANY - LANSDALE / KULPSVILLE, PA 1993-1998

Engineering and design enterprise for Ford, Mazda, and Toyota brands.

Senior Product Design Engineer (1997-1998)

Performed cruise control electronic assemblies design changes and

functional enhancements. Project manager for product launches, hardware,

and firmware changes across 3 manufacturing sites. Supported the quality

department, manufacturing/ industrial engineers, and electronic

technicians.

. Led electronic amplifier assembly redesign for TQCM (Total Quality and

Cost Management) initiative employing statistical mathematical models

for manufacturing costs, process defects, in-field vehicle warranty

accounting, and component cost tracking.

. Generated time management plans for Ford's phase-in and parts

obsolescence strategies in conjunction with PPAP (Production Part

Approval Process) meeting critical cost management goals.

. Developed/enhanced Ford's SPC (Statistical Process Control) automated

manufacturing process programs via CIM (Computer Integrated

Manufacturing) program in tandem with Quality Department.

. Created product test plans for PDP (Product Development Process)

compliance that verified design performance, product life and

durability, manufacturing process capability, in process

functionality, and production runs statistical auditing.

Advanced Engineering Project Manager (1993-1997)

Established internal procedures compliant to ISO 9001 standards.

Developed hardware/software design procedures including CTP catalog of

designs. Created CTP hardware requirements, functional and design

specifications to meet operating conditions in international

manufacturing plants and government regulations.

. Designed data-driven software architecture using GUIs to generate test

plans interfacing with instrumentation and configure test reports.

Software architecture minimized coding complexity and enabled

designers to swap or replace similar classes of instruments with

minimal code base impact.

(Continued)

. BRIAN A. LISIEWSKI

(Page 3)

. Developed proprietary self-paced ANSI C++ programming training course

for an international software application delivered to both in-house

engineers and test engineers located in manufacturing plants.

BELL ATLANTIC (VERIZON) - MALVERN, PA 1986-1993

ISO 9000 certified corporation providing diagnostic and integrated software

design/development, reverse engineering, and video distribution systems to

the telecommunications industry.

Electronics Engineer

Designed and developed diagnostic software, video distribution systems,

reverse engineering systems, and integrated software solutions. Supported

repair depot with 90 bench technicians.

. Corporate Acquisition team Member that lead migration and technology

transfer initiatives.

. Developed technician training program and educational course for

analog and digital circuit troubleshooting. Authored/implemented

repair and refurbishment procedures.

EDUCATION / AFFILIATION

UNIVERSITY OF DELAWARE - NEWARK, DE: B.S. - Electrical Engineering;

Computer Science Minor

SUSSEX TECHNICAL HIGH SCHOOL - DE: Current Advisory Board Member

Contact this candidate