ISO-9001


*Bio-Computer* Computer Chip. Contracted to write a Z-transform control algorithm for the manufacturing of a sophisticated biological computer chip. *Bio-Medical* Sorin Biomedical. Contracted to write a software program to collect FDA data for Heart Valve approval. *Certification* ISO-9001 Certification. Working with a team, we went from zero documentation to full documentation in an accelerated ten month program. Designed drawings, documents, quality assurance procedures, and maintenance procedures for manufacturing and tooling Urohealth. *Clean Room* Cybercam. A one-year project modifying PLC Ladder Logic while working in a class 100 Clean Room. *Clinical Trials* Urohealth. Provided Engineering support for preparation Medical Clinical Trials for the United States, Europe, and Japan (JIS). *Documentation* Nutrilite. Vitamin formula Process Changes to update manufacturing technology advances from manual machine control to Bar Code formula entry control. *FDA 510(k)* Urohealth Systems, Inc. Consultant and Electrical Engineer for medical device used for Provocative and Nootural data collection. Conducted Design Review Meetings, wrote Windows 95 C++ software, provided Verification Test Plan, conducted Validation Testing Procefures, Resubmitted 510(k) to FDA for software design changes.	*Fiber Optic* ALPS (ISO-9001). Installed fiber optic communication for the General Motors Line, the Chrysler Line, and the Nissan Line for mfg, automation including RF Tags, LAN, and PLC programming for ISO-9001 records. *Medical Device Directive* Urohealth. Product re-design under FDA 510(k) standards, translating to Medical Device Directive under ISO-9000 Guidelines, Design, Development, Verification, Validation, Pre-Production, Production, and Design Review, RigiScan Product line. *Risk Analysis* Dacomed. Investigated company records, inspected facilities in Minnesota, and provided written reports on medical product Risk Analysis. *SPC* Hunt/Wesson. Designed and Installed a Computer System that production staff used to read QC Laboratory results. Generated Quality Control reports for 2,000 formulas for over 5,000 Lots. *Verification* Software. Designed the Test Documents and procedure for a medical product using sofware code (440,000 lines of code). *Validation* Software. Engineered the Validation Test Reports for a medical electronics report. *QS-9000 Contracts* Fiberite. Aerospace Composites. Toyota. Catalytic Convertors.

Bio-Computer
Computer Chip. Contracted to write a Z-transform control algorithm for the manufacturing of a sophisticated biological computer chip.

Bio-Medical
Sorin Biomedical. Contracted to write a software program to collect FDA data for Heart Valve approval.

Certification
ISO-9001 Certification. Working with a team, we went from zero documentation to full documentation in an accelerated ten month program. Designed drawings, documents, quality assurance procedures, and maintenance procedures for manufacturing and tooling Urohealth.

Clean Room
Cybercam. A one-year project modifying PLC Ladder Logic while working in a class 100 Clean Room.

Clinical Trials
Urohealth. Provided Engineering support for preparation Medical Clinical Trials for the United States, Europe, and Japan (JIS).

Documentation
Nutrilite. Vitamin formula Process Changes to update manufacturing technology advances from manual machine control to Bar Code formula entry control.

FDA 510(k)
Urohealth Systems, Inc. Consultant and Electrical Engineer for medical device used for Provocative and Nootural data collection. Conducted Design Review Meetings, wrote Windows 95 C++ software, provided Verification Test Plan, conducted Validation Testing Procefures, Resubmitted 510(k) to FDA for software design changes.

Fiber Optic
ALPS (ISO-9001). Installed fiber optic communication for the General Motors Line, the Chrysler Line, and the Nissan Line for mfg, automation including RF Tags, LAN, and PLC programming for ISO-9001 records.

Medical Device Directive
Urohealth. Product re-design under FDA 510(k) standards, translating to Medical Device Directive under ISO-9000 Guidelines, Design, Development, Verification, Validation, Pre-Production, Production, and Design Review, RigiScan Product line.

Risk Analysis
Dacomed. Investigated company records, inspected facilities in Minnesota, and provided written reports on medical product Risk Analysis.

SPC
Hunt/Wesson. Designed and Installed a Computer System that production staff used to read QC Laboratory results. Generated Quality Control reports for 2,000 formulas for over 5,000 Lots.

Verification
Software. Designed the Test Documents and procedure for a medical product using sofware code (440,000 lines of code).

Validation
Software. Engineered the Validation Test Reports for a medical electronics report.

QS-9000 Contracts
Fiberite. Aerospace Composites.
Toyota. Catalytic Convertors.