Patrick Doogan Email & Phone Number

Downer'S Grove, Il

Manage and implement the responsibilities of the Quality Assurance group: - Compliance of Policies and Procedures with 21 CFR Part 11/801/803/806/820/830 and 45 CFR 160/162/164- Verification and Validation of the Joints medical device- Risk Assessment of Engineering Change Requests- Validation of internal Quality Systems- Investigation of product Complaints- Evaluation of product feature Requests- Maintaining orthopedic implant templates for use in the Joints device- Approval and Control of regulated documentation- External Audits (by the FDA or by customers)- Internal Audits- Supplier Audits- Employee Training

Schaumburg, Il

• QA Compliance: review for new and modified corporate quality systems• Validation: currently validation lead for TrackWise modules, as well as other quality systems• Business Process Modeling: developed requirements, data design, workflow design, detailed configuration design, and performed configuration for several quality processes based upon SOPs• Training: qualified trainer for TrackWise system modules

Kankakee, Il

• Authored IQ/OQ/PQ and Project Plans for a wide range of computer system projects in an FDA regulated environment. • Developed Request for Proposal documents.• Participated in requirements development.• Managed, on a per-project basis, both internal and contract resources.• Managed Change Control for over 50 projects, from initiation through closure.

San Jose, Ca

• Systems Engineer for the R2.0 Architecture of a fault-tolerant TDM/ATM/IP gateway - defined the system services and scenarios framework for implementation and interworking of voice and data protocols.• Primary author of the Requirements and High-Level Design for the AAL2 Trunking and Loop Emulation features. Defined hardware signaling and bearer traffic paths, subsystem process structure, internal/external IPC interfaces, and user-interface components.• Designed ATM subsystem API components for user applications (Voice, IP) requiring transport over ATM VCs.• Designed call processing logic for the voice-over-ATM subsystem.• Initiated project to develop formal software requirements, development and verification processes within the engineering organization.

Naperville, Il

• Served as a lead member of the 5ESS Test Process Management Team, which revised and streamlined the entire formal software verification process for the 5ESS voice/data switch.• As a lead software verification engineer, participated in requirements definition and design document review, estimated test engineer headcount required, specified test lab configuration, defined test strategy and test set, wrote Requirements Test Plan, executed tests in lab environment, and directed the activities of other team members. • Directed and trained project test teams, and mentored junior engineers in the theory and application of software verification methodology.• Designed and implemented real-time embedded software for the 5ESS Peripheral Control subsystem, to resolve user-reported issues.

Master Of Science (Ms), Computer And Information Sciences, General

Bachelor Of Science (B.S.), Physics