Michelle L. Spencer

• Managed team (of HW & SW engineers) through a first ever launch of a high compute console for medical device software in under 24 months.
• Directed project strategy and prioritization by guiding the team through defining a Minimum Viable product
• Aligned MVP, project direction, and strategy with key initiatives of business roadmap and successfully delivered all key initiatives on time.
• Collaborated with global cross-functional stakeholders to gather, clarify, and prioritize user requirements early and often through continuous feedback loops
• Directed changes to project scope and cost and implemented appropriate change management processes to keep project on track.
• Maintained schedules to meet key milestones at every project phase. (100% delivery of timeline)
• Managed and communicated project plans, schedules, risks, and progress to key stakeholders and project contributors.
• Partnered closely and often with project team members to proactively identify issues and resolve them expediently

• Lead cross-function team to develop first connectivity solution for fully integrated Q-Guidance navigation system based on diverse stakeholder user needs and technical system requirements
• Created and kicked-off company's first cross-organizational digital & new product development team
• Directed team in development of full project plan for delivery of several key data-driven business use cases; Also acted as business analyst in development of key use cases
• Directed development of data 'supply chain' to collect, ingest, and deliver key metrics from operating room to key enterprise solutions
• Successfully navigated alignment of large NPD team through diverse set of stakeholder and market requirements for new product 'Hydra' as part of the large program initiative known as "OR Integrated Stryker Experience."
• Inspired positive team engagement; creatively fostering collaboration, trust and enthusiasm for challenge in unideal working environments (e.g. significant resource & timeline constraints)

• North America Lead for Operational Technology Solutions
• Received 1st Place for 'Outstanding Newcomer Award' for Global Engineering
• Founding member of Global Manufacturing Technology Board. Built life cycle standards to minimize technical debt and creating governance and support models for production critical assets and technology
• Lead cross-organizational, multi-functional group of IT, Engineering, Quality, and Operations to implement end-to-end Manufacturing Execution Systems
• Lead creation of Risk Analysis and Failure Mode Handling plan for all production-critical systems, processes, and hardware
• Created standardized plan for Digitization of all facilities by 2025 including asset management, material traceability, inventory management, quality/SPC reporting, Predictive Maintenance, and Efficiency/OEE metrics.

• Technical engineering lead for various large capital projects
• Lead cross-functional teams of operations, R&D, and engineering to deliver solutions with high return on investment
• Lead and Generated Risk Identification & Mitigation plans for $MM start-ups
• Directed team in Design, Testing, Implementation of Batch Execution Systems for multiple large-scale Poptart process lines
• Lead Design and Installation of controls & visualization platform for large scale manufacturing lines (PLCs, SCADA control)
• Built & Standardized Data Acquisition/Historization Systems for analysis of multi-faceted manufacturing data

Eli Lilly & Co - Contracted work

• Project Lead for PLC code validation
• Performed Batch Query Validation for Proprietary Batching Software
• Developed OQ Test Cases for Code Review
• Documented issues & discrepancies for Change Controls & Created test summary reports