David J. Sauvageau
Thousand Oaks, CA 91362
****.****@*****.***
Summary/Goal
Sr. Engineer with 16 years of device experience in Medical Technology. Extensive experience in R&D, Production, Quality, Clinical Trials, Physician Partnerships, Patent & Regulatory Landscapes, Bio-materials, Surgical Implants and Fabrication Technologies. Effective developing leading Physician alliances and scientific excellence through all levels of the organization.
Experience
Sr. Engineer of Development 3/2010 – Present
Cynvenio Biosystems, Westlake Village, CA
Biotechnology start up developing a microfluidic flow cell to be used in the detection of Cancer cells.
Primary focus is to develop the flow cell and commercialize it to be be used clinical trials.
Built a team of 3D modeling designers and vendors to mold, sputter, pattern and etch flow cell.
Expand facility to have class 10000 clean room and smooth process flow for cell chip manufacturing.
Design and build laboratory grade instruments to run the flow cells and other blow molded disposables.
Completed 6 instrument platforms for protein/cell separation and liquid biopsy processing.
Sr. Engineer of R&D, Endoscopy/Oncology Division __ __ 2004 – 2009
Boston Scientific Corporation, Marlboro, MA
Technical lead for the acquisition of Catheter Innovations Inc. for $30M to include PASVtm passive valve devices and technologies for PICCS, Ports, Dialysis and Tunneled Central Catheters..
Development and launched several key platforms based upon new technologies:
Hiflotm microcather for embolic delivery. $30M annually.
Vaxceltm PICC Catheters for chemotherapy delivery. $11M annually.
Spherical PVAtm embolics for Uterine fibroid and Tumor embolization. $21M annually.
BioActive Coatings and Bioresorbable Sphere technology development.
Launched the Soloist 1.0cm, 17 gage RF probe and the RF 3000 watt generator for Tumor Ablation in Liver and Lung cancer applications. $24M annually.
Commercialized the SPY Direct Visualization System to view/capture a tissue sample from the bile duct with the SPYBite biopsy jaws. $8M annually.
Developed the manual Direct Drive Endoscopic System for Natural Orifice Translumenal Endoscopic
Surgery (NOTES) to enable the surgeon to perform endoscopic procedures without leaving scars.
Designed a Fine Needle Aspiration FNA device to capture cancer cells from the Pancreatic duct.
Sr. Engineer of Research and Development, Medtronic CardioVascular 2001-2004
Medtronic Corporation, Danvers, MA
Designed and launched new cardiology products focused on: Embolic Protection, Valve Replacement, Thrombectomy and Guide Wires / Catheters.
Initiated and completed the Interceptortm Carotid Distal Protection Filter design and trial in Europe which launched the only remote-control .014 delivery system in the market.
Integrated the PercuSurge Guardwiretm Balloon Distal Protection System from Sunnyvale, CA to Danvers, MA.
Developed and launched the market leading LaunchertmGuide Catheter line which attain 51% worldwide share within 7 months of introduction. $20M annually.
Senior Engineer of R&D, Microvasive Urology 1996-2001
Boston Scientific Corporation, Natick, MA
Performed due diligence in the acquisition of Laurus Medical Inc. for $10M to leverage laproscopic Push & Catch suturing technology for urology applications and procedures.
Developed and launched of 6 fixation systems in 3 years to provide BSC’s core technology platform in Female Urology with sales attaining $32M:
PRESS-INtmabdominal bone anchor kit eliminates the utilization of a hand drill by the Urologist.
PRECISION TACKtm transvaginal system minimizes the need for suprapubic incisions.
CAPIO CLtm, PCtm AND OPCtm suturing devices/procedures that replace permanent implants.
PRECISION TWISTtm anchors with a patented low profile delivery, 1st year sales of $8M.
Lead the reformulation of the ZENAtm dissolving ureteral stent and conducted initial human trials.
Lead the Sensortm guide wire development, market evaluation and launch. $6M annually.
Project Engineer 1991-1996
Smith & Nephew Endoscopy, Andover, MA
Developed PROLINEtm Arthroscopic instruments utilizing concurrent engineering resulting
in a highly manufacturable instrument with superior quality to conventional devices.
Acquisition and start-up of a $5M Sterile fixation screw process cell within four months from inception to stock requiring legal due-diligence, packaging and sterility validations.
Created design files, inspection criteria, GMP process summaries and training programs per ISO requirements and maintained these documents through ECO control.
Led professional cross-functional teams (Design, QA, MfgEng, Regulatory, Customer
Service and Marketing) by promoting concurrent engineering throughout members.
Process Engineer 1987-1991
Texas Instruments, Inc., Attleboro MA
Supported $60M product lines and personnel assembling 1 million electro-mechanical motor protection devices daily within UL/CSA compliance.
Initialized and implemented SPC (Statistical Process Control) certified supplier programs, capital investment projects, cost improvement programs (CIP).
Tool & Diemaker 1979-1985
Brookfield Machine Inc., West Brookfield, MA
Expert fabrication methods and materials knowledge ranging from metals, plastics and coatings. Designed and built high speed tools, fixtures and molds.
Education
M.S. Administration, Boston University 1992-1995
Boston MA
Concentration: Administration of Technology and Innovation
B.S.M.E., Central New England College 1984-1987
Worcester MA
Concentration: Mechanical Engineering
Patents, Publications and Trademarks
USP 6962588 Percutaneous pringle occlusion method and device
USP 6939355 Bone anchors for bone anchor implantation device
USP 6752814 Devices for minimally invasive pelvic surgery
USP 6748953 Method for thermal treatment of type II endoleaks in arterial aneurysms
USP 6706055 Guidewire apparatus for temporary distal embolic protection
USP 6575987 Quick connect bone suture fastener
USP 6440154 Protective sheath for transvaginal anchor implantation device