Excel in all phases of software development. 35 years experience programming in “C” (Imbedded, Windows, Unix, Web, etc.) Member of international committee that defined the FAA software development standards for ALL commercial airborne software worldwide. Highly innovative, productive, thorough and well-organized planner. Excellent communication and collaboration across functional teams and departments.

EXPERIENCE:

Litton Aero Products, Woodland Hills, CA 1984 - 1995

Supplier of commercial navigation and airborne systems.

Software Section Manager/Engineer

· Pioneered the use of “C” programming for embedded navigational software while still an undergraduate.

· Designed, coded (“C” language), and tested majority of software for navigation system used for Air Force 1 including participation in its test flights.

· Managed software development for several other navigation systems.

· As lead Systems Engineer, directed all Systems and Software activities for an integrated GPS, Air Data, and Inertial Reference systems.

· As a software development expert, represented Litton as a participating member of an international committee (RTCA/EUROCAE) responsible for defining official standards governing all worldwide suppliers of commercial airborne software.

· Used CASE tools (Software Through Pictures) to develop software requirements for a Global Satellite Navigation system applying the Hatley/Pirbhai approach to Systems/Software requirements specifications.

· Developed and implement automated test methodologies for testing critical navigation software for commercial airlines including the generation of over 4,000 automated system-level tests. (special assignment)

Software Quality Assurance Manager

· Directed software assurance aspects for twelve lines of Navigation Systems to assure compliance to FAA regulations.

· Managed the financial, administrative, and technical aspects of the SQA Department.

Pacesetter (a St. Jude Medical company), Sylmar, CA 1995 - 1998

Producer of implantable pacemakers.

· Developed the Quality Assurance Department's working instructions for managing the SQA activities at Pacesetter and achieving FDA regulatory compliance.

· Responsible for the validation of all phases of software development for two pacemaker "programmers" used by doctors to program implanted pacemakers, including the generation of automated tests written in several languages.

LifeScan (a Johnson & Johnson company), Milpitas, CA 1998 - 2004

Manufacturer of blood glucose meters and test strips.

Sr. Software Quality Engineer

· Developed and provided training to SQA staff and engineers to audit/develop software deliverables conforming to FDA regulations including 21 CFR Part 11.

· Authored Standard Operating Procedures and Work Instructions at the corporate and division level used to develop software in an FDA regulated environment.

· Trained assessor for Carnegie Mellon's SEI-CMM (Software Engineering Institute - Capability Maturity Model); participated in several CMM assessments establishing baselines for software improvement processes.

· Achieved regulatory compliance by overseeing software development on numerous major projects including manufacturing equipment and quality systems and Quality Systems.

Software Supplier Auditor

· Conducted vendor software and 21 CFR Part 11 audits on behalf of J&J Corporate on companies such as PeopleSoft-Denver (formally J.D. Edwards), MatrixOne, and Data Systems International resulting in forming a partnership to help bring their systems into compliance with FDA regulations.

· Lead software auditor for LifeScan auditing companies such as TATA Consulting - India, Hirano - Japan, Harro Hofliger - Germany, Merkle Direct Marketing - MD, Cimage NovaSoft - MA, and many more.

· Developed and standardized audit forms and processes for by Johnson & Johnson Corporate permitting divisions to share audit results and reduce costs associated with redundant vendor audits.

Flextronics (Corporate), Milpitas, CA 2004 - 2011

Global Contract Manufacturer.

Software FDA Compliance Manager

· Managed all software quality tasks used in all phases of software development for all software used for manufacturing medical devices.

· Created Policy and Procedures standards for the above stated software development tasks.

· Worked with satellite companies around the world to train and ensure compliance to FDA software development requirements.

· Personally managed all validation activities pertaining to Flextronics' self developed Manufacturing Execution System (MES) used on shop floors around the world for the manufacturing of millions of products daily.

EDUCATION:

Post graduate work in Computer Science at Brigham Young University, Provo, UT (completed course work towards Master of Science with GPA of 3.85)

B.S., Computer Science, Brigham Young University, Provo, UT

Minor in Mandarin Chinese, Brigham Young University, Provo, UT

Member of American Society for Quality Control.

COMMUNITY SERVICE:

Served as the president of a local Young Men's organization that promotes leadership skills for youth, a volunteer for the Boy Scouts of America as a Scout Master, Explorer Scout Advisor, and a Scout Committee Chairman.

Served as a volunteer in the Republic of China for two years and learned to speak fluently in Mandarin Chinese.