David Polakowski, PMP

425-577-2082 [email protected] www.linkedin.com/in/davidpolakowski/ CAREER SUMMARY Quality-driven Electrical Engineer with over 20 years experience as an Electronics Designer, Project Manager and Engineering Manager in R&D organizations for medical device companies. Strong ability to learn quickly, strategize and act with focused effort to achieve objectives. Seeking a position in Electronics Design or Management capacity that can leverage my leadership experience. QUALIFICATIONS 15 years digital hardware design, test and HW/SW systems integration for boards, FPGAs and ASICs 7 years cross-functional Project Management, PMI Certified Project Manager Dec 2012 Over 20 years R&D Engineering for Medical Devices 510k and PMA 12 years Engineering Manager of multi-discipline engineering staff of ten Working knowledge of FDA 820.30 Design Controls, ISO 13485 QSRs and ISO 14971 Risk Management Adept at developing test plans, test protocols and preparing the verification environment Expertise in Verilog coding for FPGA functional design and simulation test benches EDA tools: Mentor DxDesigner and Modelsim, Viewlogic, Altera Quartus, Xilinx FPGA Can visualize "big picture" view of complex systems and create compact, manageable design modules Skilled with analytical equipment to troubleshoot and analyze system and component problems

PROFESSIONAL HISTORY Physio-Control Redmond, WA 2011 - 2013

Senior Electrical Engineer on a team of six to diagnose and fix line-down problem with flagship defibrillator product. Wrote and co-executed hardware verification plan for FPGA design spin. Design Assurance Engineer for complex defibrillators and AEDs. Analyzed requirements, created test plans, authored test protocols, collaborated with technicians during test and wrote test reports. Lead Electronics Engineer 2010 Becton Dickinson Diagnostics Mebane, NC Completed electronics design work of a proprietary DSP and ASIC based image processing board used in 15 card slots within a precision optical/electro-mechanical cervical cancer screener system. Used Mentor DxDesigner for schematic capture and Modelsim for PC-based design verification. rd Managed 3 party PCB layout and CM for board assembly. Coordinated design hand-off to BD Engineer for first article debug/integration. Board earned FDA approval and is currently in production. Engineering Manager / Key Technical Contributor 1998 - 2009 Becton Dickinson TriPath Redmond, WA Developed and directed a multi-discipline engineering staff of 10 for incremental development of the companys flagship cancer screening system and associated auto-stage microscope products while serving parallel role as Key Technical Contributor. Collaborated with management on annual department budget determination, including contract labor. Conducted performance reviews, sought optimum solutions to load-level resources, scheduled training, authored job descriptions and interviewed candidates for open positions. Created SOPs for R&D that improved design transfer to production. Created risk assessments per ISO 14971 and provided input to design teams to create safer products. Ability to create concise, testable, technical requirements and specifications for HW/SW design teams resulting in shorter design cycles and improved project success. Lead designer of high-speed digital electronics and mentored other R&D associates. Performed root cause analysis and proposed corrective actions as a member of CAPA process. Energized and inspired my associates toward skill building, resulting in promotions.

DAVID POLAKOWSKI, PMP Senior Electronics Engineer / Team Lead (concurrent with Engineering Manager)

page 2 2005 - 2009

Saved a trending $500,000 annual loss by redesigning two proprietary boards to eliminate obsolete electronic components and improve manufacturing testability, reducing scrap. Reverse engineered obsolete VME Interface Controller component and implemented in Altera FPGA. Introduced IEEE 1149.1 JTAG components for rapid and accurate board testing on production floor. Schematic capture, BOM, cost analysis, timing verification, design reviews, design for EMI/EMC, directing PCB layout, directing proto build and performing unit test containing FPGAs, ASICs, CPUs, DSPs, image processing electronics and more. Authored OEM specifications and component specifications. Senior Project Manager (concurrent with Engineering Manager) 1998 - 2005

Seized initiative to direct five (5) revenue generating cross-functional product development projects for a FDA approved Class III medical device. Complete understanding of product development process from concept to launch. Created, tracked and adapted cross-functional schedules while driving them to completion. Fostered collaboration within project teams to maintain focus and forward progress. Leadership skills utilized during changing priorities while negotiating project plans. Key reviewer of system test protocols and test reports for design verification/validation. Chaired technical reviews, tracked action items to closure and ensured required deliverables were under Change Control and cataloged in DHF to confidently support FDA audits. Prepared meeting agendas and circulated meeting minutes to project team and senior management. Conducted project team meetings and made periodic presentations to senior management. Defined necessary DHF deliverables to comply with FDA/ISO Quality System Regulations. Senior Systems Engineer NeoPath, then TriPath Redmond, WA (promoted 1998 to Engineering Manager) 1996 - 1998

High visibility assignment to analyze poor MTBF of field units at stalled USA Clinical Trial sites. Wrote data mining Perl scripts to successfully diagnose device failures. Leader of a cross-functional team to identify, analyze, prioritize and fix problems. Within three months, MTBF improved from one (1) hour to 30 days, allowing Trial start. Drove continuous improvements that pushed MTBF beyond 180 days prior to FDA approval. Recognized by Senior Management as a builder of trusted relationships and partnerships across technical teams and functional departments inside a matrix organization, resulting in a promotion of my choice to Engineering Manager in 1998. Staff Electronics Engineer Siemens Medical Systems, Ultrasound Group Issaquah, WA Designed complex, high speed embedded boards for groundbreaking ultrasound systems. 1990 - 1996

Education / United States Patent Bachelor of Science in Electrical Engineering (BSEE), Marquette University, Milwaukee, WI Project Management Professional (PMP) credential, Dec 2012, Number 1568061 5,477,858, Norris et al., "Ultrasound Blood Flow / Tissue Imaging System", Siemens Medical Systems, Inc., Iselin, N.J.