Systems Engineer, Engineer Management

*** *** *** ** *, Buffalo Grove, IL ***** . 847-***-**** .

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

EXECUTIVE SUMMARY

. Leader of project teams and functional organizations to develop

complex medical devices and systems

. Experienced in all aspects of product development with emphasis on

systems engineering processes and leadership

. Extensive experience with requirements development, risk management

as well as Human Factors testing and design

. Hands-on manager responsible for mentoring and developing employees

. Six Sigma Green Belt certified with experience implementing DFSS

methodology for medical device development

. Proven work ethic and performance to deliver valuable and

sustainable results

PROFESSIONAL EXPERIENCE

HOSPIRA

Lake Forest, IL

Systems Engineer

Oct 2012 - Present

Infusion Pumps - New Product Development

. Leading a team of systems engineers to manage requirement

development activities for the highest priority pump program

o Supporting development of user interface detailed design

requirements in conjunction with a cross-functional team

o Performing requirement analysis activities to improve requirements

coverage and traceability

o Allocating system requirements to the subsystem functional teams

o Led the analysis of complaint data including; internal complaints,

MAUDE reports, Recalls, and CAPAs to ensure appropriate

mitigations were incorporated into the system functionality

. Led the requirements development activities for the next generation

infusion pump system utilizing SysML

o Drafted the Requirements Management Plan to describe the

development of requirements following model-based and pattern-

based systems engineering methodologies

o Established the methods used to document Use Cases using SysML

Activity, Use Case, and State Machine Diagrams in MagicDraw

o Led a team of systems engineers to develop Use Cases and

Requirements to meet customer and regulatory requirements

o Led the introduction of SysML which included tool selection,

employee training, and tool customization

o Aided the development of the system architecture using Block

Definition Diagrams

o Utilized a model-based approach to support the development of an

ISO 14971 compliant hazard analysis

. Supported the analysis and optimization of an occlusion algorithm

utilizing a functional model of the cassette silicon diaphragm

relaxation

. Analyzed complaint data to generate on-market risk assessments to

update product risk management files

Quality System Improvement - Design Transfer

. Performed root cause analysis to define the probable root causes of

the design transfer quality system issues

. Supported the development of the design transfer procedures as part

of a quality system update

BAXTER HEALTHCARE CORP.

Round Lake, IL (Aug 2009 - Oct 2012)

Senior Systems Engineer

June 2011 - Oct 2012

Renal Franchise - Peritoneal Dialysis New Product Development

. Led the planning, design and execution of DFSS activities to

support a design decision to improve device reliability

o Designed and managed the execution of Design of Experiments (DOE)

to assess various noise and control factors

o Analyzed DOE data using Minitab statistical tools to generate a

validated model to approximate the system's behavior

o Executed verification testing to confirm the effectiveness of the

design modification

. Directed the planning and execution of Risk Management activities

to assess risks for electromechanical devices and ancillary

disposable devices

o Developed a risk management process to assess risks using

quantitative probabilities to more accurately evaluate customer

risks and set thresholds for customer complaints

o Organized and led cross-functional teams to perform risk analysis

including: FMEAs, Risk Benefit Analysis, Hazards Analysis, and

Fault Tree Analyses

o Linked complaint codes to the hazards analysis to support

investigations during product support

. Performed Requirements Management activities including the

development of a DOORS project, creation and management of

requirement specifications (Static requirements and Use Cases), and

traceability analysis

. Supported the design and execution of system design reliability

activities and the investigation of device failures

. Supported the development of the listening system including

complaint codes and call scripts to capture and analyze customer

complaints and device failures

Engineering Development Program (EDP)

2009 - 2011

Participant in two-year rotational engineering training program

focused on developing high potential engineering professionals.

Rotations provided an opportunity to become experienced in a range of

engineering roles including Human Factors, Quality, and Systems

Engineering, while also learning design methodologies including

Critical Thinking, Design for Six Sigma, and Product Design and

Development.

Systems Engineer

January 2011 - June 2011

Global Infusion Systems (GIS) - Systems Design

. Supported Requirements Management activities for the next

generation Large Volume Pump

o Led the planning, design, and development of a Standards database

using DOORS to facilitate the product requirement cascade of

compliance documents

o Created a change control process and a database management plan to

ensure the completeness and accuracy of the information in the

standards database

o Assisted in the creation of System Requirements translated from

User Needs using DFSS tools (fishbone and affinity diagrams)

o Supported the identification of Critical to Quality requirements

using a Quality Function Deployment matrix

. Supported Risk Management activities for the next generation Large

Volume Pump

o Led the development of a DOORS architecture and methodologies to

support quantitative Risk Management activities

o Developed requirements to support the generation of DOORS

eXtention Language (DXL) scripts for the Risk Management modules.

Quality Engineer March

2010 - December 2010

BioLife Plasma Services - Quality

. Responsible for planning and directing the remediation of the

Design History File for the Blood Establishment Computer System,

Donor Information System (DIS) v5.0

. Introduced DOORS to the project team and led the requirement

development activities

. Managed the planning and execution of Risk Management activities

including Design FMEAs, Use/Misuse FMEAs, Process FMEAs, and Faults

Tree Analyses

Human Factors Engineer

August 2009 - March 2010

Technology Resource Engineering - Human Factors

. Led the design and execution of Human Factors studies for the

creation of requirements used for product development

. Supported Human Factors activities during the development of

Baxter's next generation automated home peritoneal dialysis device

including: GUI and device design; labeling review.

. Provided Human Factors support for the development of the automated

home peritoneal dialysis clinical software including the following:

User interface and system navigation development; Use/Misuse FMEA

and Hazard Analysis

. Supported the human factors summative study to validate user needs

and intended uses of a large volume pump.

ADDITIONAL QUALIFICATIONS

Proficient with:

System Modeling Language (SysML) DOORS - Requirements Management Tool

MagicDraw - UML/SysML Modeling Tool Minitab - Statistical Tool

Design for Six Sigma MatLab

JIRA ISO 14971

Other:

. Baxter DFSS Green Belt Certified

. Winner of the "Best Use of MBSE/SysML with Cameo Suite" award at

the 2014 No Magic World Conference

. International Council on Systems Engineering (INCOSE) - Membership

Committee Chair

EDUCATION

UNIVERSITY OF WISCONSIN - MADISON

Madison, WI

Bachelor of Science in Biomedical Engineering

Graduated August 2009

GPA: 3.8/4.0

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