Lisa Steinhoff Email & Phone Number

St Louis, Missouri, United States

> Lead engineering team in the development and support of new products and legacy systems including VITEK2, VITEK2 Compact, BacT/ALERT VIRTUO, and BacT/ALERT 3D product lines > Ensure proper resource allocation, arbitration and resolution of conflicting interests, collaboration with interfacing departments and stakeholders, and establish and manage the department and project budgets> Rebuilt hardware engineering leadership team by growing four internal employees into management roles and creating project lead role to ensure adequate collaboration of all hardware functions on key projects and to better align with the software organization> Work with hardware development team in Europe on global functional excellence and joint product development efforts> Collaborate with global and local purchasing to focus on design to cost initiative and to identify supplier pipeline of external engineering partners> Fostered positive working relationships and global connections with all system development functions including the innovation team leads to support smooth knowledge transfer from research to development > Represent Systems Development on the CAPA Board and as subject matter expert for internal and external audits > Drove and provided leadership for the following continuous improvement efforts in accordance with project, program, manufacturing, and hardware engineering needs ensuring compliance with the quality system and regulations: o Implemented use of technical design demonstrations prior to feasibility and development and verification project phase reviews o Electronic Engineering Change Management o Migration from Creo CAD software to Solidworks o Common design versioning system for R&D and Manufacturing o Use of Pilot Production instruments in clinical trials and product validation o Use of manufacturing resources in the build of prototype instruments

> Continued Management of US Microbiology Systems Test & Support maintaining global consistency with EU team> Additional accountability for Product Validation at the St. Louis Site> Responsible for team management with regards to employee / manager development, growth, and mentorship > Member of the US System Development Leadership Team working with Software Engineering, Hardware Engineering, and Biomath, on new development projects and improvements to existing products> Continued support as subject matter expert for interaction with FDA and internal auditors during site inspections

St Louis, Missouri, United States

> Managed engineers in the US and France responsible for system integration and system verification of legacy product lifecycle and new system development(Myla, VITEK, BacT/ALERT, Observa, and Previ Isola)> Oversaw third level support process for legacy product install base in coordination with Manufacturing Site Quality to ensure R&D support to the field and manufacturing for complaint management and change control processes> Recognized as global subject matter expert for planning system level verification > Global management and development of people by mentoring key individuals, managing resources and budgets for coordination of multiple development and support efforts> Domain expert for software tool used for product issues tracking, requirements managements, and verification and validation test case and test case execution management> Subject Matter Expert for direct interaction with FDA auditors during site inspections leading to standardization and process improvement for issue management and post market surveillance of product issues

St. Louis County, Missouri, United States

> Continued management and development of verification engineers including department and project budgeting, mentoring, succession planning, and performance management> Arbitrate conflicting objectives and moderate the interactions between team members and the rest of the department.>Systems integration / systems architecture team member for new product development to ensure requirements, design documentation, and integration milestones are synchronized for all necessary verification activities.>Lead implementation of the first electronic, 21CFR11 compliant, system used by bioMerieux to manage verification activities

St Louis, Missouri, United States

St Louis, Missouri, United States

St. Charles

> Served as technical liaison for surgeons and developers for neurosurgical, orthopedic, and otolaryngologic products> Responsible for installation, qualification, and servicing of stereotactic image guided surgery equipment> Provided training and written support for surgeons and staff> Managed account documentation of customer issues needed for quality management and FDA regulations

Graduate Certificate, Systems & Product Development

Masters, Engineering Management

Bs, Biomedical Engineering

Education record

bioMerieux "Fit for Future" Lead by European Center for Executive Development (CEDEP) bioMerieux Management Essentials: Management Basics.