Michael Gendreau Email & Phone Number

Santa Clara, California, United States

Fremont

R&D of a Class III Peripheral vascular drug eluting stent for the treatment of critical limb ischemia- Managed project to transition from concept feasibility through first in human trials- Lead design validation and verification (DV) including the following; corrosion testing (BDP and Galvanic), pulsatile durability, flat plate crush, particulate, Simulated Use, material characterization, packaging validation, sterilization validation, Implant radial stiffness, delivery system development, and Biocompatibility- Wrote protocols/reports and worked closely with regulatory to provide European Notified Body and FDA with timely submissions and responses- Performed risk management effort for BTK DES Implant – Human Factors/Hazard Analysis, dFMEA, and pFMEA- Created realistic simulated use model- Evaluated competitive product to enumerate the stat of the art with regard to on label commercially available devices

Menlo Park

Research and Development of the Parachute Implant, a Class III cardiovascular implant for the treatment of congestive heart failure- Managed project to transition an internally produced Nitinol Shape Set Implant frame to an externally sourced component- Led design verification (DV) by leading corrosion testing (BDP), microstructure analysis, 600 million cycle fatigue, Simulated Use, material tensile, Implant stiffness, Implant dimensional and geometry inspection, Oxide surface analysis (thickness and constituency), and Nickel Release testing- Wrote protocols/reports and worked closely with regulatory to provide European Notified Body and FDA with timely submissions and responses- Led Risk management effort for Parachute Implant – dFMEA and pFMEA- Worked closely with suppliers to provide detailed component specifications and to validate manufacturing processes for Nitinol Implant Cross Pin and overmolded polymeric Implant Foot.

Sunnyvale

- Southeast Region Commercial and SLED Accounts- Top ISR Activity Q1 thru Q3 FY2014- Worked with Field, Channel, and Internal HP Sales Ops team to close business and exceed customer expectations- Coordinated with Field Reps and Sales Development Reps to develop and maximize out bound marketing effort

330 Gibraltar Drive Sunnyvale, Ca 94089

- North Central Region Commercial and SLED Accounts- Surpassed quota in first full quarter with highest call activity (3600 calls/emails)- Collaborated with sales, channel partners and marketing to facilitate new programs, messages and offerings- Developed inbound leads from various sources and qualified business potential

San Jose, Ca

- Worked with Physicians to better serve their clinical needs with next generation products- Participated on cross functional teams to interpret and comply to FDA and European regulatory bodies- Managed suppliers, vendors and technicians to monitor and supervise fabrication or services to maintain product development timelines and deliverables

Menlo Park, Ca

- Worked with customers to quote, develop and sustain new products, acting as the overall project manager- Provided guidance to customers as necessary- Designed robust, cost effective tools/processes and oversee prototype fabrication- Troubleshooted problems and define preventative and corrective actions- Supported internal development projects and goals- Developed new surface finishing processes and techniques, such as, chemical etching, electro polishing, and passivation

• Specified, designed, and drafted system components and/or modifications to existing system components• Developed conceptual prototype devices and system components• Utilized FEA to develop and refine designs for nitinol stents for TAA and AAA Endografts• Conducted and documented testing/evaluations of new designs concepts or system components• Managed, utilized, and developed external suppliers• Worked with and supported manufacturing in the development of manufacturing equipment, procedures, and processes• Applied engineering principals to practical design and development applications with a hands on development/prototype approach• Complied with regulatory requirements for implantable medical devices• Highly productive and motivated member of many cross functional teams ranging from design, development, failure analysis, process improvement and compliance teams• Developed novel graft material process, patent pending

Laser Engineer - Interfaced with customers to develop design specifications- Programmed and coded laser cutting systems used in the manufacturing of stents or similar devices and products- Prepared detailed drawings and schematics of designed products- Planned and developed experimental test programs and analyzed test data to determine if design meets functional and performance specifications- Developed models of alternate processing methods to test feasibility of new applications of system components and recommended implementation of improved procedures- Created tooling and prototype processes for shape setting of stents and other articles- Supervised the Laser Technician- Participated in cross-functional teams to provide technical information and engineering solutionsProcess Engineer- Worked with customers and manufacturing to design products and the tools, equipment, and processes- Troubleshot problems and defined preventative and corrective actions- Documented tasks including creation of required prints, work instructions, and specifications- Presented findings or oral arguments to customers and management when necessary- Trained operators in processes and methods of manufacture and quality systems

- Designed and fabricated coronary stents (both stainless steel and Nitinol)- Developed manufacturing processes for coronary stents- Trained technicians to perform various manufacturing processes - Initiated change orders to documentation for R&D stent projects- Authored Material Specification for tubing vendors- S-N Testing of Nitinol- Created Test Methods for receiving inspection