President of SDLC Compliance and MedDev Consulting & Engineering

• Aug 2022 - Present

Software Quality / Risk Management Remediation

• Sep 2020 - Present

President / Principal Consultant

• Jan 2017 - Present

President and Principal Consultant serving the Medical Device Industry. Specializing in SDLC, SW V&V, Project Management, Testing, Risk Management, Remediation Efforts and more. www.meddev-ce President and Principal Consultant serving the Medical Device Industry. Specializing in SDLC, SW V&V, Project Management, Testing, Risk Management, Remediation Efforts and more. www.meddev-ce

PROGRAM MANAGER / SCRUM MASTER

• Jun 2019 - Sep 2020

OmniPod Insulin Management Delivery System: Managed the design and commercialization aspects of key new products with responsibility for driving collaboration of cross-functional product commercial teams. • Effectively lead project teams in a collaborative environment, completing project deliverables per target timelines and requirements. • Participate in and /or oversee all design and process validation activities required for assigned projects. • Acted as the internal liaison between engineering, marketing, manufacturing, RA/QA and sales management for the purpose of scheduling projects, driving the timely launch of projects, budgeting resources, and reporting on the progress of several projects that are simultaneously being prepared for commercialization. Engaged externally with various teams to support innovative commercialization efforts. Show less

SOFTWARE REMEDIATION LEAD / MANAGER Software Remediation

• May 2017 - Feb 2018

*Tracking of SW development requirements to IEC 62304 *Guide SW development while creating new developmental processes *Provide current industry standards and techniques in SW development, Requirements management, and testing. *Writing and reviewing of requirements, SW V&V, SW tools, etc. *New product development projects for complex electro-mechanical devices with embedded SW *Configuration and Implementation of Defect Tracking Tool *Leading SW Remediation Effort *Creating updating of Corporate SOP and SW Design and Testing Protocols Show less

SR. REMEDIATION LEAD (Quality, Process, & Risk Management Remediation)

• Jan 2017 - Apr 2017

•Monitor and continuously improve the Quality System by evaluating supporting documentation to ensure compliance to cGMP, industry standards and other applicable regulations. •Provides guidance and control directives regarding remediation activities required to continue production. Is required to resolve critical issues within area assigned and may escalate to senior management team based on severity of the issue. •Responsible for providing quality oversight to the change management system for complex Minor and/or Major classified Change Controls. This includes providing plan creation oversight, verifying that changes adhere to local SOPs and regulatory compliance and ensuring communication/escalation of potential issues of broader impact to the business. •Write and review standard operating procedures, test methods, work instructions, forms, material specification sheets, master batch records, and production batch records, deviations, CAPA’s, change controls and other relevant GMP records for compliance. Show less

SR. SOFTWARE QUALITY ENGINEER / NEW PRODUCT DEVELOPMENT (Medical Device)

• Mar 2014 - Nov 2016

• Arthroscopic Energy Generator and Surgical Pump projects: Apply SDLC and Agile software quality assurance techniques, requirements creation, acceptance criteria, functional design, technical design, and use case design documents to determine testability and adherence to IEC 62304 Standards. Create detailed test plans, and test strategies to meet project goals, while improving of the quality of product software. Updating and creation of Company Wide SOP’s; • Managed engineering resources, Defect Identification, Triage, and Resolution. Assessed the condition and quality of software builds, releases, and bug fixes and creation of Validation Summary Report. Risk Management (DFMEA/FHA), CAPA Investigation and Resolution. Active member of company Steering Committee Show less

SR. QUALITY REMEDIATION LEAD (Medical Device)

• Oct 2013 - Mar 2014

• Electrosurgical Power Tools: Provide direction, guidance, review and Remediation of client’s processes. • CAPA Investigation of Root Cause, Execution and Resolution. FMEA Reports, Process Risk Mitigation Plans and Process Validation Plans. Reviewed, amended, and wrote applicable SOP's. Assures cGMP, SOP, FDA compliance, and Process Verification Efforts • Electrosurgical Power Tools: Provide direction, guidance, review and Remediation of client’s processes. • CAPA Investigation of Root Cause, Execution and Resolution. FMEA Reports, Process Risk Mitigation Plans and Process Validation Plans. Reviewed, amended, and wrote applicable SOP's. Assures cGMP, SOP, FDA compliance, and Process Verification Efforts

ENGINEERING MANAGER (Medical Device)

• Nov 2012 - Sep 2013

• Negative Pressure Wound Therapy Electromechanical Pump Device: Responsible for supporting and assuring the completion of the validation and process engineering project milestones • Creation of master validation plan and timelines; Oversaw the Validation Engineering Group, Software Developers, Electrical Engineers and Quality Assurance in project planning, execution and validation processes; Collaborate with Director of Engineering in identifying and resolution of product defects, Project Progress and Timelines. • Support and coordinate the integration of new projects into the validation/process engineering project list Show less

SR. TECHNICAL PROJECT MANAGER (Medical Device)

• Mar 2012 - Sep 2012

• Arthroscopic Energy Generator & Oxygen Concentrator Projects: Development of Project Timelines, responsible for developing SOW, business proposals, financials, and managing medium complex medical device projects globally, & ensuring all of the project's technological requirements and / or objectives are met • Managing Project’s Key Success Indicators, scope, quality, time and cost constraints. Project Risk/Design Reviews were conducted to ensure all FDA/Manufacturing guidelines are met; Communication Management of all stakeholders. Forecasting project budget and resource needs • Accountable for project success, including cost, schedule, quality, scope management, and customer satisfaction. Ability to form / lead strong multi-functional teams to achieve company and customer objectives Show less

SR. SOFTWARE VALIDATION ENGINEER / MANAGER (Medical Device)

• Nov 2010 - Mar 2012

• Cellular Analysis System, Automated Hematology Analyzers Projects: Conduct engineering tests; prepare engineering and validation reports, plan and schedule projects in a manner consistent with organizational objectives. Worked with product design team to develop appropriate test coverage to requirements; Requirements Management and Traceability • Developed technical test plans wrote test cases, analyze and verify any issues discovered, log potential software defects into a defect tracking database, and reviewed test data with team members • Created summary reports for all tests conducted and distribute as required. Prepared documentation required by FDA, interpreted and evaluated test results. Improved the process of updating and quality assurance during the validation and execution phase of the project by implementing both Six Sigma and Agile Software Process Show less

SR. SOFTWARE QUALITY REMEDIATION LEAD (Medical Device)

• 2012 - 2012

• Wireless Blood Monitoring System: Create and supervise the implementation of test plans, protocols and activities • Requirements Management and Traceability; ensured the test process & documentation conformed to requirements and IEC62304 • Participate in planning and implementation of test tools, test automation frameworks, test processes • Develop test protocols, implement test tools and supporting infrastructure, and perform hands-on testing • Wireless Blood Monitoring System: Create and supervise the implementation of test plans, protocols and activities • Requirements Management and Traceability; ensured the test process & documentation conformed to requirements and IEC62304 • Participate in planning and implementation of test tools, test automation frameworks, test processes • Develop test protocols, implement test tools and supporting infrastructure, and perform hands-on testing

Software Validation Engineer

• Mar 2009 - Sep 2009

• Developed test cases and verified software test cycle within the product development life cycle of digital cable (SET TOP BOX), Home content sharing prototype, and software builds • Tested VOD, PPV, DVR, via the use of Motorola DAC, AP Test Manager, Build++, and Bugzilla; Requirements Management and Traceability . • Developed test cases and verified software test cycle within the product development life cycle of digital cable (SET TOP BOX), Home content sharing prototype, and software builds • Tested VOD, PPV, DVR, via the use of Motorola DAC, AP Test Manager, Build++, and Bugzilla; Requirements Management and Traceability .

RF TEST ENGINEER

• Oct 2008 - Mar 2009

• Dept. of Defense High Security Military Project: Generated formal test procedures for qualification of electronic systems to military and environmental requirements • Set up of test equipment & environment, RF communications testing, GPS modules, RF antennas testing & flashing of all embedded systems firmware-testing from the component to system level • Dept. of Defense High Security Military Project: Generated formal test procedures for qualification of electronic systems to military and environmental requirements • Set up of test equipment & environment, RF communications testing, GPS modules, RF antennas testing & flashing of all embedded systems firmware-testing from the component to system level

SR. TECHNICAL PROJECT MANAGER

• Feb 1999 - Jan 2005

• Dept. of Defense High Security Military Project: Planned, scheduled and coordinated technical and management aspects of projects. Interacted with assigned project clients to determine customer requirements • Prepared engineering project proposals, budget monitoring and trend tracking. Participated in client/contractor meetings, resolving client/engineering, and management project issues. Overall execution of project and constraints • Dept. of Defense High Security Military Project: Planned, scheduled and coordinated technical and management aspects of projects. Interacted with assigned project clients to determine customer requirements • Prepared engineering project proposals, budget monitoring and trend tracking. Participated in client/contractor meetings, resolving client/engineering, and management project issues. Overall execution of project and constraints