Working on all things software process related

Performed remediation of Design History Files based on Audit of DHF content, Functional & Physical Configuration audit reports and gap analysis reports.• Coordinated project software documentation for IDE, PMA, & 510(k) submission packages and response letters to the FDA.• Certified compliance to IEC-62304:2015 for legacy software of on market products sold in Japan. • Provided oversight & guidance of test execution activities. Conducted readiness reviews and validation of test environment. Reviewed & approved test plans. procedures, test results, and Summary reports. Conducted risk assessment of all open issues and dispositioned accordingly. • Internal Audit Team Lead Auditor, External Audit Team member with ‘Front room’ experience, and Supplier Quality Auditor.• Quality Core team member for design remediation and software re-factoring, Design History File remediation, and establishing Quality Agreements /SLAs with Contract Manufacturers.• Validation Team lead for conducting Intended Use Validation of Software tools and non-product software, used in Production and QMS support.• Lead contributor to continuous improvement initiatives for maintaining QMS policies, procedures, work instructions, and templates for compliance with ISO-13485, ISO-14971, IEC 60601, IEC 62366, IEC-62304 and cGMPs.• Knowledgeable in system development & software architecture for embedded systems utilizing SAFE RTOS operating system.• Experience validating private and public cloud configurations (IAAS,PAAS) and the deployment and provisioning of micro-services for support of manufacturing, data security, device communication, patient data (PHI), and customer care.• Project Software and Design Quality lead for new product software for Cloud-based systems, SaMD’s, and mobile accessory application Software (Android and iOS platforms).• Experience working with all development methodologies and SDLC models for medical device Software, SaMD, commercial and consumer product Software.

• Collaborate with subject matter experts, business analysts, and Design engineers in the collection of intended use requirements for Test tools used in the manufacturing of DUV (Deep Ultra Violet) Excimer Laser Lithography systems.• Create User Needs, System and Sub-system requirements documents for test software used to verify laser control systems and system components. Includes High Voltage Power Supply modules, Beam Splitters, Alignment Optics and Wavemeter calibration modules. • Create Zephyr test stories and test suites for verification of laser control systems and associated modules using JIRA. Collected test results and laser output data for comparative analysis of beam stability and energy stability. Provided Test Reports and Analysis for each test cycle and Summative Test Report. • Perform Laser Laboratory setup, configuration of Laser system control software, module hardware interfaces, and testing conduit for the formal execution of test cases. • Provide test data analysis, feedback, and test improvement recommendations to business analysts and design engineers for addressing issues discovered during testing.

• Review and approve all software work products, project software deliverables, and product software release documentation for laboratory diagnostic tests, laboratory platform software, scanner cell image capture & assay algorithm development.• Provided oversight for compliance to FDA IVD regulations, IEC 62304, ISO 13485, and ISO 14971. • Developed operating procedures for performing Hazard Analysis, Risk Assessments, Change impact Analysis, and Regression Analysis.• Core-team Quality representative supporting product software development Provided control and oversight of the software change management process ensuring impact analysis and design updates from software changes were documented and approved.• Responsible for reviewing and approving software change requests, revision/version updates and software implementation deliverables.• Approved the release for use and removal from service of all software-controlled Laboratory Equipment. Approved IQ/OQ/PQ protocols & reports, reviewed maintenance and calibration logs, vendor service files.• Analyze Quality metrics to identify trends/improvement opportunities and present data to Quality Management and Senior Management for review. Participated in the corporate compliance program documenting, assigning, and tracking Quality Events like Incidents, Deviations, Nonconformances and CAPAs. • Reviewed CAPA plans, tracked all corrective action activities, effectiveness checks to completion. • Participated in Quality audits for the internal audit program, supplier audits, 3rd party audits by Sponsors, Regulatory and Notified Body audits.• Created Protocols for validating 3rd party integration with Salesforce Trackwise e-QMS, DMS, TMS Modules for Epic Sciences configuration. Produced Validation and Deployment Reports required for release into production.• Maintained accurate and detailed records in accordance with GLP, GCLP and CAP, CLIA regulations.

• Senior consultant assigned as core team Quality representative for Philips’s flagship ventilator, the VX850, and the V60 series of ventilators. • Worked with Business Unit process owners and Global IT to create Non-product Software System Validation deliverables for applications supporting manufacturing and the Quality Management Systems. Documents included Intended Use Requirements, Functional Requirements, 21 CFR Part 11 assessments, Validation Scalability Estimates, System Risk Assessments, IQ, OQ, PQ Protocols and Reports, Validation Summaries and System Change Requests• QMS Quality Engineer coordinating and managing ECR’s, ECO’s, change control of relevant documentation and artifacts for submission and approval to Document Control.• Participated in Design Reviews and Peer reviews for approval of ventilator design documents, software deliverables, and test cases/procedures.• Participated in Code Reviews using Code Collaborator and monitored unit testing and integration testing.• Coordinated software release candidate ECO’s for internal release to manufacturing engineering and R&D engineering.

• Technical Architect and System Integration team manager tasked with developing Test Strategy, Test Planning, and schedule for conducting End to End testing of GreatCall's network, systems, and subsystems.• Collaborated with Scrum team to review epics, feature/development stories, and participate in grooming backlog for determining new end to end scenarios and impact on existing user workflows, business processes, back-end dataflows, message endpoints and system integration touch-points.• Designed & developed End to End test scenarios to ensure implementation of user and business workflow changes, customer account creation/modification, customer billing, mobile device provisioning, voicemail, text and emergency response system subscriptions with Verizon and T-Mobile carriers for Best Buy Health consumer products for monitoring the elderly.• Reviewed system-level design changes conducted risk-based change impact analysis to determine affect on user & business workflows, back-end processing, and data integrity.• Assisted development with application and subsystem dependency mapping,• Collaborated with DevOps to implement system and network End to End test execution as part of all customer beta tests, release trains, product launches and rollbacks.• Created test stories for all defects and issues which were placed in the backlog and worked with Scrum Master and Product Owner to move test stories into the sprint planning process. • Authored End to End Regression Analysis Reports, Test Summary Reports and provided recommendations for approval to release.

• Provided Software quality oversight and guidance for projects developing Cloud-based applications, SaMD applications, and mobile accessory applications as part of a Personal Diabetes Management portfolio including a Concentrated Insulin Delivery System, insulin pump controller SDK, and Artificial Pancreas closed loop system (Class 2 &3).• Initiated R&D Software Engineering Process Group meetings. Conducted meetings with cross functional team to review current processes, identify process gaps, initiate SOP updates, as well as provide input to process improvement initiatives.• Created and conducted in-house training sessions for ISO-13485 , 21 CFR 820.30 Design Controls, IEC-62304, ISO-14971 and IEC 60601-1 (PEMS). Sessions were presented to Software Development, Software Test Engineering, and other R&D technical staff.• Reviewed project planning documents, design control deliverables, risk documentation, and project level operating procedures for conformance to Insulet’s QMS and documentation standards.• Authored code review plans and reports, unit test and integration test plans and reports. Verified code changes and merges in build files generated from a continuous build system. Promoted/rejected build files to be used as verification candidate builds.• Participated in/led 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 software change management, software configuration and software release management, as well as defect tracking and reporting activities.• Insulet 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.

• Software/Firmware Lead for remediation of Design Control, Risk Management, and Software Engineering processes for compliance to CFR 21 820.30, ISO 13485, ISO-14971 for the development of Bayer’s 2nd Generation TENS device, Wireless Remote, and Mobile Application.• Performed the roles of Software Project Manager, Requirements SME, Risk/Reliability Engineer, Independent V&V Lead, and Software Release Engineer.• Project Liaison for external development partners in Memphis, TN., Barcelona, Spain, and Melbourne, Australia.• Participated in cybersecurity vulnerability and threat assessment activities. Familiar with ISO-27001 and CVSS.• Collaborated with development to assess SOUP and OTS Software components integrated into product software to ensure safe operation using FDA guidance.• Managed the integration of iOS and Android native mobile application code changes and builds using XCODE, Android Studio, Bitbucket, Bamboo, Gradle and Jenkins.• Coordinated the implementation of firmware architecture modifications involving the 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.

• 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, code inspection processes, and IMAGIX Software Reverse Engineering tool.• Collaborated with the Fresenius 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.

• Senior Systems Engineer for CareLink Therapy Management Software Engineering group.• Responsible for requirements elicitation, definition, refinement, tracing and establishment of baselines to produce Product-level requirements, system and subsystem requirements for CareLink Personal and Professional Web Services.• Requirements team SME for system quality and performance requirements• Created departmental operating procedures (DOP’s) for use at the project level for Software configuration management, requirements definition and requirements management, Software design, and Software issue identification.• Created project level plans such as Design and Development Plans, Software Development Plans, Software Configuration Management Plans, and Software Maintenance plans.• Reviewed department operating procedures for compliance to internal processes, QMS procedures, and work instructions.• Validation lead responsible for creating Development Plans, User Needs, Intended Use Requirements, Product Requirements Specifications, Verification and Validation Plans for Development Tool set (infrastructure), COTS, and internally developed Software tools used for formal verification, field services utilities, and customer-facing accessories.• Participated in the allocation of Software requirements for automation and manual testing.• Developed scripts in Selenium IDE using Selenium Web Driver to create user scenarios for java-based and .NET web services applications.• Performed manual and automated testing of REST API and SOAP UI based, Software test tools and customer facing applications.• Code Collaborator and Perforce Administrator. Back up administrator for Quick Build and Jenkins build tools.

• Responsible for providing Software quality oversight for new product development, product sustainment, and validation of manufacturing support Software for “research use only” and FDA regulated in vitro diagnostic equipment.• Performed assessments of Software development activities for compliance to Software development processes and procedures• Reviewed and approved Software development work products for new products, Software change requests/ orders for sustaining products.• Participated in risk-based assessments for intended use validation of Laboratory Information Systems (LIMS) Software, COTS, and internally developed Software used to support the Manufacturing floor and/or integration with the Manufacturing Enterprise System (JDE/SAP).• Reviewed and approved Master Validation and Software Validation Plans, User and Software Requirements, Validation Protocols, Qualification Summary Reports and Validation Reports for process Software used in Manufacturing.• Contributed to the Quality System Improvement Plan for Software Lifecycle Management processes and Validation of Computer Systems and Development and Validation of Spreadsheets for calculations.

• Responsible for providing Software quality ‘basis of estimates’ for new contracts, RFP’s and quotes for project schedules and ensuring customer quality assurance requirements are met.• Quality Lead auditor responsible for conducting and/or participating in: QMS audits by external agencies (NAIC, NUPIC, NRC, ISO) and Project-level audits for compliance to 10 CFR 50 Appendix B, operating procedures, and contract requirements.External audits, Commercial Grade Surveys, Evaluations for ‘Approved Supplier’ status and Vendor selection.• Responsible for authoring and executing Software Quality Assurance Plans. Audit software development activities and work products for compliance to plans, procedures and software engineering processes. Generated Software Quality Assessment Reports for review by Senior Management.• Conducted Audit Reviews to report audit findings and observations. Initiated Corrective Action/Preventative Actions (CAPA’S) for all non-compliances.• Reviewed CAPA plans performed effectiveness checks to verify correction action implementation.• Participated in phase reviews to report audit results, assessment of planned vs. actual project work, Software development activities and deliverables for the phase, non-conformance metrics, and Quality approval for phase entry/exit.• Developed, implemented, and trained project staff to the following Operating Procedures: Software Lifecycle and Development Process,Software Development Plan/Template,Software Risk Management, Hazard Analysis and FMEA Process Software Inspection and Review Process,Tools Validation ProcessSoftware Issue Identification Process, Software Verification ProcessRequirements Definition and Requirements Management Process• Lead contributor to Validation Team responsible for performing intended use validation of QMS support Software, LMS learning system Software, and manufacturing workflow Software.

• Ensured that all project deliverables meet Device Design Control requirements.• Performed project phase audits to establish conformance and compliance to 21 CFR 820, Corporate and Site Operating Procedures, as well as Project level procedures.• Responsible for conducting risk assessments, HAZOP, FMEA, PFMEA. Performed HALT, HASS testing.• Responsible for reviewing and approving Software development artifacts, Software requirements, product requirements, and user needs documents.• Performed audits to ensure compliance to Software Design Process for both internal and external work partner development.• Initiated Exception Reports to address Non-compliance Issues and tracked/monitored progress through the CAPA system to ensure effectiveness checks are performed.• Participated in weekly external work partner Design and Technical Review meetings to ensure development is on track and outstanding issues are addressed.• Participated in:Code reviews, Design reviews, Unit & Integration Test Reviews, Software Program Management Reviews,Software & System Hazard Analysis• Provided weekly Software quality metrics to senior management such as: Code completion/ Feature complete percentage, Defect Removal Effectiveness, Requirements Stability, Code Complexity, Phase Containment (limited)• Participated in the Software Process Engineering Group forum to review current processes for process improvement.• Performed bi-annual updates to existing Site Operating procedures.• Authored and/or implemented Site Operating Procedures:• Reviewed and approved test cases and test procedures for Software verification testing.• Reviewed and approved Software build packages.

(Secret Clearance)