Engineer Medical

Brandon James Kulawik, E.I.T.

**** ********** **** 704-***-****

Dover, FL 33527 ***************@*****.***

SUMMARY: Detail-oriented leader with comprehensive design and project

management experience in ISO regulated medical R&D, production and contract

manufacturing environments. Proficient in all aspects of product design and

development with a desire to exercise and adapt my electrical and

mechanical aptitude.

EXPERIENCE Engineer, February 2011 - Present

Rhein Medical, Inc. - St. Petersburg, FL

-Advised clients during 510(k) product submissions; collaborated with lab

facilities to analyze bioburden levels per AAMI/ISO 11737 standards and

validate sterilization protocols

-Managed new product designs through prototype, functional testing and

commercialization stages; evaluated injection molding, medical packaging,

machining and manufacturing vendors per product requirements

-Proposed budgets, timelines and resource allocation for new product

development and contract manufacturing

-Generated process specifications, operational procedures and work

instructions per ISO 13485 QMS.

-Designed, constructed and qualified assembly fixtures, generated BOM's and

technical drawings

-Managed production personnel and analyzed work flows to improve efficiency

and throughput

-Installed and maintained cleanroom environments and workstations from

Class 100-100,000

Equipment / Operations Engineer, January 2007 - April 2009

Qimonda Semiconductors - Richmond, VA

-Oversaw the design, installation, maintenance and decommissioning of

highly automated manufacturing equipment. Balanced the day-to-day

maintenance and operational requirements of these toolsets.

-Critiqued maintenance specifications and procedures to improve equipment

stability, reliability and production yield. Provided hands-on training,

supervision and daily work allocation to equipment technicians.

-Managed budgets and reduced operating costs by 30% through validation of

second source opportunities, process improvements, and optimization of

equipment preventative maintenance schedules.

-Utilized Golden Tool Analysis, Statistical Process Controls and DMAIC

process with IE and L6S teams to characterize equipment behavior, formulate

root cause analysis and eliminate yield and throughput detractors

-Led task forces to improve equipment uptime from 78% to 92% and avoid a

$7M capital expenditure.

-Established Key Performance Indicators (KPIs) and a PM history database to

benchmark and improve equipment maintenance, reduce production impact and

minimize qualification time post-PM.

Co-op, August 2006 - December 2006

Baxter Healthcare - Marion, NC

-Upgraded and reprogrammed HMI and PLC control systems within automated

manufacturing equipment

-Developed and constructed a test fixture to monitor the seam quality and

burst capacity of medical IV pouches

-Administered software license database and assessed obsolete network

equipment within a production plant

Intern, May 2006 - July 2006

TriE Medical, Inc. - Morrisville, NC

-Amended developmental schematics in Visio and modified PCBs to reflect

redlined drawings

-Assembled prototype medical equipment according to design schematics and

mechanical AutoCAD drawings

-Coordinated with Software Engineering and a machine shop to develop and

fabricate test fixtures to verify the functionality of component PCBs and

video display systems.

Co-op, May 2005 - January 2006

Parata Systems - Durham, NC

-Utilized micro I/O controllers to detect failure mechanisms throughout

simulated product lifecycle

-Performed failure analysis of RMA components to classify design flaws and

reduce customer returns

-Integrated thermocouples and LabView software to monitor product

performance

SKILLS Microsoft Word, Excel, PowerPoint, Visio, Project, AutoCAD,

Solid Works, ISO 13485, ISO 9001, QMS, LabView, Java and C Programming,

Allen Bradley PLC Experience, Lean Six Sigma, 5S Coordinator

EDUCATION North Carolina State University, Raleigh NC, July 2006 - Magna

Cum Laude

Bachelor of Science in Electrical Engineering, Bachelor of Science in

Computer Engineering

ACTIVITIES NCSU Dean's List, University Scholars Program, Member Eta Kappa

Nu International Honour Society

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