Mike Geatz Page 3 of 3

PROFESSIONAL SUMMARY

Well versed in FDA 820 and European CE regulatory requirements, Mike founded the world’s largest hypoglycemia symptoms alarm manufacturing company and brings over 20 years’ experience as a senior level product development professional for medical device companies in both lead and hands-on roles.

MAJOR ACCOMPLISHMENTS

  • Managed product development of a hypoglycemia symptoms alarm that has grown into the world’s largest.
  • Managed product development of a physiological sensor technology and sold the company to a US$ billion international firm.
  • Managed implementation a biometric security system that is currently processing millions of visitors crossing the border into the Kingdom of Saudi Arabia.
  • Obtained regulatory approval for a medical device in Europe, Canada and several Middle Eastern and Asian countries.
  • Setup a manufacturing quality system and obtained ISO13485 certification.
  • Built a European & Middle East distribution network to drive exponential revenue growth.

PROFESSIONAL WORK EXPERIENCE

Consultant, Software Quality Engineer 2009 to Present

As an outside consultant, Mike's provided software quality assurance and automation testing services to help numerous companies develop and bring their products to market. These services include working with regulatory agencies, vendors and outside labs in addition to offering expertise in the following,

·  Quality Management Systems.

·  FDA 820.30, ISO13485, IEC 62304.

·  Corrective and Preventive Actions (CAPAs).

·  Design History Files (DHF) and Technical Files.

·  Applications for CE, FDA 510(k) and Healthcare Common Procedure Coding System (HCPCS).

Clients include,

Thomson Reuters, Denver, CO 2013 to Present

Terumo Heart, Ann Arbor, MI 2012 to 2013

Rockwell Automation, Phoenix, AZ 2011 to 2012

Towers Watson, San Diego, CA 2010 to 2011

Northrop Grumman, Sierra Vista, AZ 2010

Abbott Molecular, San Diego, CA 2009

CSC Arabia, Riyadh, Saudi Arabia 2006-2007

Director, Product Development & Intl. Sales 2009 to Present (part-time)

GIANT MEDICAL & GIANT BIOSENSOR, USA & Hong Kong 2005 to 2009

A medical device company specializing in the design, development, manufacture and sales of physiologic monitoring and medical symptom alert technologies. Systems include a non-invasive diagnostic device to detect symptoms of hypoglycemia and a bed motion monitor to detect epilepsy seizures during sleep.

Defined and executed a strategy to position Giant Biosensor’s hypoglycemia symptoms alarm as the world’s leading device in terms of revenues, units sold and worldwide market penetration.

  • Managed Product Development within time and budget parameters.
  • Opened and managed two regional offices in areas with the highest growth potential.
  • Setup distributors and key customers in each of the Gulf Cooperation Council (GCC) countries of the Middle East and United Kingdom.

·  Oversee product Quality Assurance and Quality Control manufacturing procedures in accordance with ISO13485 standards.

·  Establish and maintain regulatory compliance in each territory.

·  Represent the company at international conferences and other customer related events.

·  Conducted distributor training and attended joint sales calls with distributors.

  • Grew business at rates exceeding 20% in sales and profits.

Vice President 2002 to 2005

PULSETRACER TECHNOLOGIES INC, Vancouver, Canada

A venture capital funded wellness lifestyle management company that combines entertainment and social networks with a wrist worn lifestyle monitoring device. PulseTracer’s development efforts are consolidated into a miniaturized, low power, sensing module capable of verifying metabolic rate, caloric output, and activity - drawing upon activity and heart rate indicators from within a simple wrist worn device that requires no electrodes, chest straps, or finger contacts.

As a member of the senior management team, primary responsibilities included managing product development and establishing strategic partnerships.

·  Named inventor of wrist pulse sensor technology.

·  Managed engineering services contract for development of a proof-of-concept prototype.


Additional Experience

·  Author of Data Mining: A Tutorial-Based Approach, Addison-Wesley Longman (2004).

·  Adjunct university faculty instructor and guest lecturer on "Automated Systems Testing".

·  Private pilot.

Education

·  Master of Business Administration in Management, Golden Gate University

·  Bachelor of Science in Computer Science, University of North Dakota

Certifications

·  Certified ISO13485 Internal Auditor

·  Certified Software Test Engineer

·  Mercury QTP and TestDirector

Professional Affiliations

·  Quality Assurance Institute (QAI)

Standards

·  FDA 21 CFR Part 11

·  FDA 21 CRR Part 820.30 Design controls

·  IEC 62304

·  ISO 13485

·  ISO 14971

·  HP QTP

·  IEEE 829 Standard for Test Documentation

·  FDA General Principles of Software Validation

Tools

·  IBM DOORS

·  IBM ClearQuest

·  IBM ClearCase

·  Microchip MPLAB

·  TI Code Composer (‘C’ Programming)

·  AutomatedQA TestComplete

·  MS Office

·  MS Project

·  MS Visual Source Safe (VSS)

·  HP Quality Center

·  MathWorks Polyspace

·  Seapine TestTrack

·  Seapine SCM Surround