Frederic Declerck

**** ***** ****** #*** ********, IL 60201

acumvy@r.postjobfree.com, 312-***-****

An accomplished systems engineer with extensive knowledge of the full product life cycle of medical equipment. Highly experienced in requirements definition, proof of concepts, design, testing and support. Specialized in verification of software implementation, system design as well as system validation (user needs) with a track record of delivering products free of safety defects. Engineer with highest number of system issues uncovered for most projects worked on. Professional Experience

Principal Engineer at Fresenius Kabi, Lake Zurich, IL 2012-Present Lead System Validation Engineer on Pandora, the next generation plasma collection device (launch expected in 2016). Led a team of 7 engineers. Planned, designed and performed testing sessions in multiple countries in order to validate the instrument user needs.

Lead System Verification on Aurora/Andora, plasmapheresis and therapeutic instrument. Led a team of 6 engineers. Wrote plans, reports and technical design reviews. Supervised context validation sessions for translations of the user interface in multiple languages. Developed, supervised, executed and reviewed risk-based test protocols.

Provided guidance to other lead engineers working on other projects. Principal Engineer at Fenwal Lake Zurich, IL July 2008-2012 Lead system verification Engineer on Aurora, a new plasma collection device (launched in 2012). Designed system level testing activities, conducted regression analysis in a risk-based testing context. Planned, designed and conducted validation and usability studies in house and also in Germany and Austria. Part of the group that defined new verification and validation processes. Risk–based process includes:

Heavy emphasis on safety

Statistical analysis

Consistent use of rationalized least favorable conditions

Injections of faults from use errors to software and hardware failures

Reports including extensive risk assessment

Session based ad-hoc tests

Hudson group contracting at Fenwal Lake Zurich, IL March 2006-July 2008 Lead engineer for verification cycles on Auto-C, a plasma collection instrument deployed worldwide. Led system verification activities (test plan, test report, test protocol writing, updates, execution and reviews). Visit customer sites for problem investigations.

Coordinate a global team of verification engineers. Hudson group contracting at Baxter Healthcare, Round Lake, IL July 2005-March 2006 Software Verification Engineer on ALYX project (a mobile RBC collection unit) Responsible for:

Troubleshooting the instrument and investigating issues (especially related to safety features).

Writing and keeping software verification documents up-to-date. Hudson group contracting at MPC Products (now Woodward), Skokie, IL July 2004-July 2005 Software engineer:

Project ETRAS (Electrical Thrust Reverser Actuation System) for Airbus A380 (through Hispano-Suiza): Worked on a board based on 21992 ADSP (analog device) with assembly code to control brakes. Quickly studied existing code and was sent over to customer site (Réau, France) to integrate our hardware. Debugged both software and hardware issues. Assured successful launch and delivery of project (no defect ever reported after integration phase). Frederic Declerck – Page 2

Main projects:

GUI development to communicate with our board products from a standard PC. GUIs were developed with CVI Labwindows. Communication was established through serial, USB and/or CAN lines.

Simulators to speed up development without complete hardware. C applications simulating communication from CAN and USB devices.

Assembly applications for Analog Device 219x processor (DSP). Design and implementation of DSP applications to drive brush and brushless motors.

Software Design Engineer at GE Healthcare, Waukesha, WI 2001-2004 Member of a global software team located in India, China, Hungary, France and the US. Daily communication with colleagues around the world in order to complete key development steps: design, presentations and support. Member of a group developing low layer software used in 6 x-ray instruments incorporating 6 Sigma quality standards. Implemented RTComm, a real-time driver that allowed control of key features such as triggering x-ray exposures. Written in C++, this driver is scalable to various hardware boards and runs on VxWorks and Linux. Developed DeviceComm, a C++ component interfacing with Can and CanOpen drivers that provide the software positioner team a simple way to access and move hardware. It was compiled for several operating systems and handled various hardware boards.

Coded the Virtual Operator, a mixed Java/C++ distributed component using CORBA. This component allowed a user to simulate a sequence of keyboard and mouse events and has been used daily for 5 ongoing years. Education

M.S., computer engineering, Ecole Polytechnique de l’universite d’Orleans, Orléans, France, 2001

Professional Scrum Master Certification (PSM1 – obtained on 04-27-2016)

6 Sigma Green Belt certified (while working for GE Healthcare) Internships at:

Kohnolab, National University of Yokohama, Japan Summer 2000 High Temperature and Plasma Laboratory, University of Minnesota, Minneapolis, MN Summer-Fall 1998 Alcatel, Orme, France Summer 1997

Computer skills

Operating Systems Windows, Unix, Linux, QNX, VxWorks Languages C, C++, Visual C++, Java, Pascal, Assembly, Tcl/Tk, Labview, Labwindows, CORBA Tools Clearcase, Clearquest, Rose, DOORS, ReqPro

Related Experience And Activities

Volleyball Playing: 26 years of competitive play indoors and beach volleyball. As the team captain, I have led several travelling teams throughout the years including trips to Nationals. Coaching: 11 years of experience coaching travelling Junior teams and sharing my passion for the game. Specifically, I enjoy building strategies to beat teams that have a physical or technical edge over mine. Strategy

Games

Plan, prepare, setup and advertise strategy games day long tournaments for about 20 players on regular basis.

Languages Fluent in French (Native speaker)

Proficient in Spanish (studied for 6 years, several trips to Spain and Mexico)

Contact this candidate