Diane O'Shea Email & Phone Number

Gulf Shores, Al, Us

• Manage the customization, configuration, and integration of the Trackwise Digital Quality Management System, based on Salesforce, for a Fortune 500 company with $34+ billion in yearly sales. • Work with a team of Project Managers to manage the timeline, scope, quality, and resourcing utilizing Agile rolling planning of a multi-year implementation spanning many Epics.• Facilitate Agile processes and ceremonies utilizing Azure DevOps.• Ensure developed system complies with corporate and project requirements, including system integrations and security.• Ensure compliance with government policies, regulations, and procedures including FDA 21 CFR. • Lead and manage subcontractors and multiple vendors, both onshore and offshore.• Coordinate a large number of highly detailed IT infrastructure requests and dependencies.• Proactively manage dependencies, identify and mitigate risks, and perform issue root cause analysis.• Own the User Stories and acceptance criteria for integrations between Trackwise Digital and external systems, including vendor systems, enterprise databases, and the Dassault Regulatory and Product Stewardship System (RaPSS). Facilitate all integration testing.• Develop regular project dashboards; interact with multiple levels of management to present updates. • Implemented DevOps process improvements for Quality Assurance related to test development, dry run, automation, planning, and offshore management, eliminating the need for one full time resource and saving the project $200k over the next year.• Managed the test case automation of 300+ tests by a third-party vendor, saving hundreds of hours of test time by business Subject Matter Experts over multiple years. • Facilitated the Sparta (Honeywell) AI training and business user acceptance of the Trackwise Digital MedDRA complaints classification module. • Host bi-weekly retrospectives with cross functional teams. Create DevOps tasks for selected improvements and track to completion.

Oceanside, California, United States

Provided team and process improvement services to privately owned small businesses with revenue of $1M-$2M. • Assisted small business owners in determining the root cause of various team, process, and operational issues based on reported and observed symptoms. • Provided leadership coaching to improve team relationships, clarify roles & responsibilities, and improve delegation and time management.• Assisted business owners in evaluating current team skills and structure and advised on team structure, role, and responsibility changes where appropriate. Develop plans for team changes.• Evaluated current processes for the 10 types of possible process waste in conjunction with the business owner and direct reports. Taught owners how to develop impact matrices to prioritize solutions for process improvements.• Advised owners on process improvement plans, including evaluation of new software systems where appropriate.• Assessed critical KPI’s (Key Performance Indicators) based on company’s specific industry and goals. Ensure KPI’s can be measured using existing or new software systems. Create processes around how often KPI’s are evaluated, who is responsible, who is included, and advise on how to brainstorm and evaluate ideas to course correct when necessary.

Vista, Ca

LBS develops hardware and software for the digitization, scanning, and viewing of tissue slides for cancer research and diagnostics. • Facilitated a core team including Product Management, Regulatory, QA, Manufacturing, Hardware Engineering, Software Engineering, SQA, Tech Pubs, Ops, and Cybersecurity, distributed across multiple countries. • Established project scope and actively managed changes for large, complex product development projects.• Designed, executed, and monitored projects through each phase gate of the FDA R&D cycle for CE IVD and/or FDA medical device new product development. Agile software development. • Facilitated completion of the rigorous documentation requirements of FDA product development projects. • Leveraged technical knowledge and experience to intimately understand system design and risk factors. • Worked closely with non-technical team members to develop comprehensive timelines (milestones, deliverables, tasks, resources) utilizing Visual Project Management, supported by refined, detailed rolling 4-week plans.• Coordinated, managed, and facilitated changing staffing requirements throughout the project lifecycle.• Proactively identified and managed risks and regularly resolved technical and team issues. • Managed product quality in conjunction with product managers, software development, SQA, and regulatory stakeholders. • Facilitated the procurement of project hardware, software, clinical study sites, validation sites, and all other project needs.• Worked closely with non-technical team members to develop comprehensive timelines.• Coordinated with software development team to ensure Agile planning was accurate and realistic.• Facilitated the establishment of cybersecurity processes and SOP deliverables for each phase gate as required for IVD-R product registrations.• Established and provided formal communication plans and reporting of project status, activities, changes, risks, and issues for senior management.

Greater San Diego Area

Tandem develops the next generation of intelligent insulin pumps for people with type-1 diabetes. • Evaluated, selected, and implemented new software application and processes for the development and translation of 350+ page user instructions. Increased productivity by 250%.• Worked with product managers, UI designers, software developers, and operations teams to plan, manage, and release medical device labeling for PMA and 510k submissions, including clinical studies, for a range of projects within an Agile software development environment.• Worked closely with UI designers to ensure device instructions were complete and accurate. • Ensured all Tandem design standards were followed in conjunction with the marketing creative team. • Authored press releases and blog posts and facilitated content review. • Worked with Product Managers on the authoring of clinical trial statistics and results for FDA new product submissions.• Facilitated the translation and release of software UI and all labeling into 13+ languages.• Participated in the strategic long-term planning of medical device labeling for all products while adhering to FDA and CE regulations.

Greater Grand Rapids, Michigan Area

This experience was a series of long-term contract positions, each developing custom front end UI and supporting backend enterprise integrations. • Developed advanced technical knowledge of the various enterprise systems and integrations across the whole of the Priority Health IT infrastructure, including sales, individual and small business enrollment, Facets integrations, billing, underwriting, large group enrollment and management, and provider enrollment and management.• Managed the concept, definition, planning, and execution of multiple multi-year projects involving large cross-functional distributed teams. • Defined project charters, scope, budget, schedule, resourcing, quality, and change management plans.• Performed proactive continuous project risk assessment and mitigation to ensure projects met all definitions of success.• Facilitated the selection of multiple vendors and providers of enterprise systems and contract staff to strategically supplement existing organizational systems and resources.• Facilitated and negotiated vendor proposals and contracts.• Facilitated story development, prioritization, sprint planning, daily standups, sprint reviews, and sprint retrospectives for projects lasting 3-24 months.• Coordinated decision-making between various business and technical departments for optimized strategic alignment.• Developed and continuously improved project management processes to maximize the efficiency of project teams.• Developed, measured, and reported program and project metrics; continually assessed program health.• Monitored and reported program schedule and financial metrics.• Coordinated the alignment of multi-project program initiatives, including milestones, technical requirements, and integrations.• Interfaced with many levels of the organization to continually assess changing business needs and project requirements; continually managed stakeholder expectations.

Greater Grand Rapids, Michigan Area

Large Scale Web Application Redesign. This project was a complete redesign of the extensive front end UI and supporting backend systems for a global enterprise eCommerce site for both individual shoppers and business owners. Facilitated implementation with various enterprise applications and databases, including replacement of the content management system. 150+ globally distributed resources.• Operated as a Principal IT Project Manager for the redesign of the extensive Amway website and backend systems, and pre-release activities for rolling global implementations.• Designed and facilitated high level technical estimation processes involving globally distributed resources across multiple multi-million dollar project initiatives. • Interviewed business owners and stakeholders from various departments to establish and document business requirements.• Facilitated the translation of business requirements into UI design and backend technical requirements. • Facilitated requirement and UI design reviews and iterations with business stakeholders, UI designers, and software developers.• Developed and continuously improved design and communication processes involving globally distributed teams.• Developed and maintained detailed schedules, resource plans, budgets, communication plans, and quality metrics.• Interfaced with many levels of the organization to determine changing business needs, project requirements, and to continually manage stakeholder expectations.• Interfaced with managers, project managers, business analysts, UI designers, information architects, software designers, and software developers in order to ensure a common understanding of project requirements. • Worked with vendors to ensure adherence to schedule, quality, and budget for outsourced tasks.• Actively mitigated project risks and managed issues through to resolution.

Bsee, Engineering

Master Of Fine Arts - Mfa, Creative Writing

Bachelor Of Science (Bs), Electrical And Electronics Engineering

Bachelor Of Science - Bs, Electrical And Electronics Engineering