- Twenty plus years combined experience in the implementation, maintenance, and continuous improvement of Quality Management Systems (QMS), Quality Manuals, Policies and Procedures, and Work Instructions.
- Expert knowledge in product development planning, execution of planned tasks and activities, and establishing of design controls for complex, safety critical software and systems.
- Extensive technical knowledge of software testing and design verification & validation of new and existing products and services developed in a highly regulated environment.
- Proven ability for ensuring compliance to regulatory requirements and industry standards for software design & development, design verification and validation, installation/check-out and release & maintenance.
- Expert in developing test case designs, test scripts & suites as well as performing regression analysis recommended test approach.
- Managed the test automation efforts for IBM/Rational Software, Segue, Compuware, Winrunner and Loadrunner Interactive Test Tools.
- C, C++, C#, Delphi
- Visual BASIC, .NET
- SQL, JAVA, PLM
- INTEL ASM-48,51,96, 8086
- Selenium, Mercury Interactive Test Director, Winrunner, QuickTestPro, LoadRunner 7.0
- IBM/Rational Software Performance Studio 2000, 2001
- IBM/Rational Test Suite 2002, 2003
- Rational Unified Process, Rose Modeling, ClearQuest, Requisite Pro/Requisite Web Robot
- Robot J, Test Manager, Test Factory, Load Test
- Compuware QA Run, QA Load
- Segue QA Partner
- Microsoft Visual Test
Principle Software Quality Engineer
- Provide software quality oversight for multiple projects developing new product software (Class 2 & 3, Safety Classification C medical devices) for a Personal Diabetes Management system, Concentrated Insulin delivery, pump controller SDK, and closed-loop Artifical Pancreas system.
- Initiated R&D Software Engineering Process Group (SEPG) meetings. Conducted meetings with cross functional team to review current processes, identify process gaps, initiate QMS updates, as well as provide input to process improvement initiatives.
- Created and conducted in-house training sessions for ISO-13485 QMS for Medical Devices, 21 CFR 820.30 Design Controls, IEC-62304 Software Lifecycle Management Processes, ISO-14971 Risk Management for Medical Devices and IEC 60601 Electrical Safety Testing (PEMS). Sessions were presented to Software Development, Software Test Engineering and other R&D technical staff.
- Review project planning documents, design control deliverables, risk documentation, and project level operating procedures for conformance to Confidential ’s QMS and documentation standards.
- Participate in or lead Phase Gate reviews, Technical reviews, and formal Design reviews throughout the SDLC.
- Core Team Quality representative and Software Quality Cross Functional Team (CFRT) member with Project Approval Authority engaging in design change and ECO change management, software configuration and software release management as well as defect tracking and reporting activities.
- Confidential Deputy Quality Management Representative for San Diego site responsible for coordinating and managing FDA and other external auditor onsite visits, as well as state and local regulatory inspections.
Project Software Quality Liason
- Software/Firmware Lead for remediation of Design Control and Software Engineering processes for compliance to CFR 21 820.30, ISO 13485, ISO-14971 for the development of Confidential ’s 2nd Generation TENS device, Wireless Remote and Mobile Application.
- Performed the roles of Software Architect, Requirements Analyst, Risk/Reliability Engineer, Independent V&V Lead, and Software Release Engineer.
- Performed the functions of Software Quality, Design Quality Assurance, and Project Liaison for external software development partners in Memphis, TN., Barcelona, Spain, and Melbourne, Australia.
- Coordinated the implementation of firmware architecture modifications involving the replacement of the device’s microcontroller System-on-a-Chip, a complete re-write of the SOC code, and added functionality to the device User Interface. Changes included integration of Nordic Semiconductor nRF 51822 “System on a Chip” incorporating a 2.4 Ghz BLE/RF interface, BLE communications protocol stack, and Enhanced Burst Mode libraries to communicate with an existing Wireless Remote and the Aleve Direct Therapy Mobile Application (Android & Apple IOS).
- Responsible for ensuring the planned software development lifecycle activities, all software work products, and software-related project deliverables complied with ISO-13485, ISO-14971 and IEC-62304.
- Created Product & Software Requirement Specifications, Risk Analysis and Software Hazard Analysis Document, Software Development Plans, Software Configuration Management Plans, Software Architecture and Design Documents, Unit Test Plan & Reports, Integration and System Level Test Plan & Reports, Test Protocols, and Design Verification Test Summary documents.
- Supervised the acceptance of “production-ready” software releases packages and deliverables from external partners into Confidential ’s software maintenance environment.
Software Quality Engineer
- Performed remediation and reverse engineering of embedded software and firmware of Fresenius’ Dialysis machines as Software Engineering consultant for the “Rise and Design” project.
- Provided input to the Remediation Plan for scheduling of software remediation activities.
- Performed a gap assessment audit of existing product DHF for software-specific documentation and deliverables. Prepared a list of missing or deficient documentation with proposed solutions and man hours required for each.
- Reverse engineered Fresenius Dialysis machine system and component software/firmware using code walkthroughs and code inspection processes and using IMAGIX Reverse Engineering software tool.
- Collaborated with the Fresinius software development team to gain understanding of Dialysis Machine system components, interfaces and theory of operation. Dialysis Machine software system included multiple master/slave processor configurations controlled by a pre-emptive, deterministic Real Time Operating Systems
- Performed software requirements definition and development based on reverse engineering results and software development team approval. Generated Software Requirements and Design Input specification documents using Cognition Cockpit.