SUMMARY OF SKILLS

• More than twenty years of Medical Device Development and Program Management Experience
• Manage and lead cross functional project teams, external clients and suppliers
• Project Planning, MS Project, MS Office
• Medical device product development
• Managed programs from concept through commercialization
• Excellent written and verbal communications with diverse backgrounds and all levels
• Product design, fabrication, testing, documentation  and release of medical devices
• Plastic parts: design, materials selection, fabrication and joining
• Project documentation:  design history file, verification and validation plans, protocols, reports
• Run and document team meetings, FMEA, design reviews

EXPERIENCE

Confidential
 Program Manager (Contractor) (February 2010 – Present)
Provider of healthcare products in the field of ENT (Ear, Nose and Throat).

• Managed cross function project team (10+ members) in the development of device for treating chronic sinusitis.
• Directed activities between internal cross-functional team to execute project plan.
• Developed detailed project timelines using MS Project.  Updated in response to changing regulatory strategies.
• Prepared meeting agendas, ran and documented meetings.
• Drove key decisions affecting project scope and time line.
• Prepared and delivered presentations to Sr. Staff with project status, issues, plans and team recommendations.
• Maintained design history file per FDA regulatory requirements. 

Confidential
 Project Leader (Contractor) (April 2006 – November 2009)
Contract design, development and manufacturing firm to the medical device industry.

• Project Manager for five projects:  Introducer System for Laser Therapy, Vascular Access Device, Endometrial Applicators for delivery of High Dose Radiation, Surgical Device for treatment of Macular Degeneration, Instrument Set for delivery of RF Probe to the vertebral nerve
• Primary client interface for project.  Worked with clients to define deliverables (scope, schedule, and budget).
• Regularly updated clients with project status, issues and plans, addressed client’s concerns and responded to changing priorities.
• Generated project plans and detailed project time lines using MS Project.
• Directed activities between internal cross-functional team, suppliers, and clients to execute project plan.  
• Developed product documentation including meeting agenda/minutes, verification and validation test plans, protocols and reports, and maintained design history file per FDA regulatory requirements. 
• Prepared documents for regulatory filing.
• Reviewed billing and tracked project expenses.

Personal Sabbatical (2003- 2006)

Confidential
 San Carlos, CA, Manager Sensor Engineering (2000 - 2002) 
Provider of healthcare products in the field of newborn baby care.

• Developed five products from product definition through market release.
• Designed, developed and market released disposable Ear Coupler, Acoustic cable assembly, Electrode sensor set, and Electrode cable for next generation newborn hearing screening device.
• Designed and developed cost reduced disposable Ear Coupler.
• Generated product documents:  requirements, verification and validation test plans, procedures, protocols and reports and patent disclosure. 
• Wrote project plans and detailed time lines.  Interfaced with cross functional team and vendors, ran/documented project meetings. 
• Hired Engineer and Technicians.

Confidential

•  South San Francisco, CA, Manager Sensor Engineering (1995 - 1999)

Start up founded for the development of a continuous non-invasive blood pressure monitoring product.

• Managed group of six in the R&D of the “Patient Attach” portion of the device.
• Produced prototypes to support early research in non-invasive blood pressure measurement.
• Translated research concepts to product designs.
• Built prototypes, performed testing and evaluation of prototypes, documented results.
• Interfaced with Scientists, Engineers, Technicians and Consultants.
• Developed project plans, hired Engineers, created and maintained document control system.

Confidential
 Redwood City CA, Project Manager. (1994 - 1995)
Provider of Atherectomy systems for removal of plaque from coronary arteries.

• Managed group of 13 in the development of an ultrasound Guided Directional Coronary Atherectomy system.
• Directed development of Atherectomy catheter prototypes with ultrasound transducer tip, hand piece and ultrasound instrumentation.
• Generated Project schedules ran project meetings interfaced with Regulatory regarding regulatory strategy and Marketing regarding product concept and features.
• Interfaced with Physicians and managed logistics to test first in humans (OUS).

Confidential
 Sensor Product Development Manager (1989 - 1994)
Provider of Pulse Oximetry and Airway Management Products.

• Managed a group of nine in the development of new disposable and reusable Pulse Oximetry Sensor products. 
• Managed resources, contributed technically, and addressed global issues to support the Sensor business and to enable the Sensor group to develop/market release 10+ new sensor products.
• Regularly updated Sr. Management with project progress, issues and plans, addressed field questions, compatibility issues and competitive assessments.  Documented results.
• Wrote patent disclosures, worked with attorneys to defend company patents.
• Interfaced with Marketing, Manufacturing and Clinical Studies departments to support ongoing and proposed projects.
• Interfaced with Marketing and Senior Management, to set strategic direction for the Sensor Business Unit. 
• Developed and managed department budget. 
• Hired Engineers and Technicians, wrote/delivered employee reviews.

Confidential
 Senior Sensor Engineer (1986 - 1989)

• Project Engineer and Project Manager responsible for the complete development of reusable Pulse Oximetry Sensor products.  Developed and brought three sensor products to market.
• Designed and developed sensor prototypes for early research in Fetal Oximetry. 
• Clinically tested Fetal Oximetry prototypes.

PATENTS

6 patents issued, 1 patent pending.

EDUCATION

M.S. Engineering Sciences (Bioengineering).  .
B.S. Mechanical Engineering,