About Hector Guestrin
SUMMARY
An experienced professional with solid education and demonstrated success in process management. Expertise in Medical Devices; Quality Management Systems for compliance with FDA, Health Canada and EU regulations and standards; Requirements Management; Risk Analysis; Quality Assurance; SW Verification & Validation; SW Configuration Management and SW development management. Highly analytic and problem solver. Good communication and presentation skills. Reputation for fine interpersonal and coaching skills. Effective management of local and remote teams. Experience in Biomedical Engineering, particularly in biomedical instrumentation and optical-fibre sensors for chemical and biological measurements. Fluent in English, Spanish and Portuguese.
EXPERTISE
· Medical Devices
· Quality Management Systems
· Regulatory Affairs: FDA Regulations; Health Canada and European Union Standards
· Product Lifecycle Management
· Risk Analysis
· Process, project and people management
· Requirements Management
· Quality Assurance
· SW Configuration Management
· SW Verification & Validation
· HW Validation
· Inspections
· Traceability
· Product internationalization
· Lab installation and support
· Digital video products
· Optical-fibre chemical sensors
· Biomedical instrumentation
· Six-Sigma Green Belt
· Extensive research experience in academia and industry
TOOLS (See Professional Development)
· Project management
· Requirements management
· Configuration management
· Development
· Testing
· Traceability
· Issue-tracking
SECURITY CLEARANCE
· Reliability Status
EXPERIENCE
Consultant - Cumulus Dental Inc., Ottawa, ON - December 2013 - Present
Consultant - Analytics for Life Inc., Kingston, ON - October 2013 - March 2015
Consultant - Health Parametrics Inc., Ottawa, ON - January 2014 - December 2014
Manager, Quality & Regulatory Affairs - Therapeutic Monitoring Systems Inc., Ottawa, ON - 2011-2013
SW Quality Control Coordinator - Sander Geophysics Ltd., Ottawa, ON - 2009-2012
Verification & Validation Manager - Honeywell Video Systems, Ottawa, ON - 2000-2008
Engineering / Management Staff - Mitel Corporation, Ottawa, ON - 1995-2000
EDUCATION
PROFESSIONAL DEVELOPMENT
Management
· Sustained Creativity - Mitel Corporation
· Providing Constructive Feedback - Mitel Corporation
· Managerial Effectiveness - Mitel Corporation
· Performance Management Training - Mitel Corporation
· Performance Coaching Training - Mitel Corporation
· Change, Participation and Leadership Workshop - Mitel Corporation
· Memory Skills - Mitel Corporation
Quality
· ISO and FDA Awareness - Emergo Group
· Testing in the Real World - Software Quality Engineering (SQE)
· Software Testing Tools - Software Quality Engineering (SQE)
· Six-Sigma Plus for SW Development - Honeywell
Technical
· SX-2000 Installation & Maintenance - Mitel Corporation
· Smalltalk - Bytesmiths Object-Oriented Training
· Programming in VisualWorks - The Object People
· DOORS User Training - Quality Systems & Software (QSS)
· Objectory Training Course - Rational Software Corporation
· Robustness Analysis - Rational Software Corporation
· Object-Oriented Project Management - Rational Software Corporation
· Object-Oriented Analysis & Design - Rational Software Corporation
· Use-Case-Driven System Development - Rational Software Corporation
· Object-Oriented Design Patterns - Advanced Concepts Centre, Lockheed Martin
· Introduction to Rational Rose/C++ Using UML - Rational Software Corporation
· Introduction to GemStone - GemStone Systems, Inc.
· ObjecTime New User Workshop- ObjecTime
· ClearCase and ClearQuest - Rational Software Corporation
An experienced professional with solid education and demonstrated success in process management. Expertise in Medical Devices; Quality Management Systems for compliance with FDA, Health Canada and EU regulations and standards; Requirements Management; Risk Analysis; Quality Assurance; SW Verification & Validation; SW Configuration Management and SW development management. Highly analytic and problem solver. Good communication and presentation skills. Reputation for fine interpersonal and coaching skills. Effective management of local and remote teams. Experience in Biomedical Engineering, particularly in biomedical instrumentation and optical-fibre sensors for chemical and biological measurements. Fluent in English, Spanish and Portuguese.
EXPERTISE
· Medical Devices
· Quality Management Systems
· Regulatory Affairs: FDA Regulations; Health Canada and European Union Standards
· Product Lifecycle Management
· Risk Analysis
· Process, project and people management
· Requirements Management
· Quality Assurance
· SW Configuration Management
· SW Verification & Validation
· HW Validation
· Inspections
· Traceability
· Product internationalization
· Lab installation and support
· Digital video products
· Optical-fibre chemical sensors
· Biomedical instrumentation
· Six-Sigma Green Belt
· Extensive research experience in academia and industry
TOOLS (See Professional Development)
· Project management
· Requirements management
· Configuration management
· Development
· Testing
· Traceability
· Issue-tracking
SECURITY CLEARANCE
· Reliability Status
EXPERIENCE
Consultant - Cumulus Dental Inc., Ottawa, ON - December 2013 - Present
- Consultant on QMS and regulatory affairs for the company's medical devices.
Consultant - Analytics for Life Inc., Kingston, ON - October 2013 - March 2015
- Implemented the Quality Management System (QMS) for medical device development under FDA and ISO 13485:2003 compliance
- Created medical device software development procedures compliant with IEC 62304:2006
- Provided training on Standard Operating Procedures
- Provided guidance on Product Lifecycle Management
Consultant - Health Parametrics Inc., Ottawa, ON - January 2014 - December 2014
- Provided consulting service on medical devices, QMS and regulatory affairs.
Manager, Quality & Regulatory Affairs - Therapeutic Monitoring Systems Inc., Ottawa, ON - 2011-2013
- Implemented the Quality Management System (QMS) for medical device development under FDA and ISO 13485:2003 compliance
- Created medical device software development procedures compliant with IEC 62304:2006
- Provided training on Standard Operating Procedures
- Conducted the Risk Analysis of the medical device
- Coordinated the FDA 510(k) submission, resulting in a prompt clearance
- Started the Requirements Management process.
SW Quality Control Coordinator - Sander Geophysics Ltd., Ottawa, ON - 2009-2012
- Introduced SW processes in order to improve product quality
- Implemented various SW Quality Control initiatives
- Introduced System Requirements Specifications for new projects
- Gathered requirements for an improved flight navigation system.
Verification & Validation Manager - Honeywell Video Systems, Ottawa, ON - 2000-2008
- Managed QA, V&V, SW tools and IT
- Created the Verification & Validation process for digital video products, involving teams in Ottawa, ON; Syosset, NY; Surrey, BC; El Paso, TX; and Bangalore, India. The methodology included formal Use Cases, Test Cases, Test Plans, Criticality Analysis, Test Readiness Reviews and Metrics
- Promoted the Requirements Management process
- Introduced the Change Management process and tools
- Created the Release Management procedure and documentation
- Managed teams in Ottawa and Bangalore, India (up to 10 direct and 10 indirect-report members)
- Managed the development of SW installation and SW licensing
- Acted in the whole product lifecycle, from Marketing to Manufacturing and Support
- Project Manager (acting) in the 2007 version of the digital video recording product.
Engineering / Management Staff - Mitel Corporation, Ottawa, ON - 1995-2000
- Created the SW Verification & Validation group in the Strategic Technology department
- Introduced QA and V&V activities in the existing development process
- Created the Software Inspections Guide, which included: Process; Object Lifecycle and Traceability; Reporting Forms; Inspection Checklists
- Created Use Case and Test Case templates
- Managed and planned SW testing in an iterative development
- Managed team members’ activities in the development of test-harnesses and simulators.
EDUCATION
- Ph.D. in Instrumentation and Analytical Science - UMIST, University of Manchester Institute of Science and Technology, UK - 1992
- M.Sc. in Biomedical Engineering - Coordination of Post-Graduate Programs in Engineering, Federal University of Rio de Janeiro, Brazil - 1986
- Electrical-Electronics Engineering - Faculty of Exact, Physics and Natural Sciences, National University of Córdoba, Argentina - 1974
PROFESSIONAL DEVELOPMENT
Management
· Sustained Creativity - Mitel Corporation
· Providing Constructive Feedback - Mitel Corporation
· Managerial Effectiveness - Mitel Corporation
· Performance Management Training - Mitel Corporation
· Performance Coaching Training - Mitel Corporation
· Change, Participation and Leadership Workshop - Mitel Corporation
· Memory Skills - Mitel Corporation
Quality
· ISO and FDA Awareness - Emergo Group
· Testing in the Real World - Software Quality Engineering (SQE)
· Software Testing Tools - Software Quality Engineering (SQE)
· Six-Sigma Plus for SW Development - Honeywell
Technical
· SX-2000 Installation & Maintenance - Mitel Corporation
· Smalltalk - Bytesmiths Object-Oriented Training
· Programming in VisualWorks - The Object People
· DOORS User Training - Quality Systems & Software (QSS)
· Objectory Training Course - Rational Software Corporation
· Robustness Analysis - Rational Software Corporation
· Object-Oriented Project Management - Rational Software Corporation
· Object-Oriented Analysis & Design - Rational Software Corporation
· Use-Case-Driven System Development - Rational Software Corporation
· Object-Oriented Design Patterns - Advanced Concepts Centre, Lockheed Martin
· Introduction to Rational Rose/C++ Using UML - Rational Software Corporation
· Introduction to GemStone - GemStone Systems, Inc.
· ObjecTime New User Workshop- ObjecTime
· ClearCase and ClearQuest - Rational Software Corporation