Rachael Crabb Email & Phone Number

Minneapolis, Minnesota, United States

• Developed Smartsheet schedules and trackers for multiple projects including Aggregate Safety Reporting trackers
• Facilitated workshops to design future state for Reference Safety Information (RSI) processes at top-20 and mid-size pharma companies
• Facilitated workshops for Problem Definition, Root Cause Analysis, and Solution Design across international cross-functional contributors for ways of working improvement project for a top 10 pharma company.
• Supported clients from planning through implementation via schedule development and maintenance, status updates, visual timelines, risk register, change management, communication, and coaching.
• Sharepoint SME for project teamsites and department sharepoints

Virtual

• Developed Smartsheets schedules with linked deliverables for BioPharma Startup projects.
• Facilitated workshops for Problem Definition and Root Cause Analysis across international cross-functional contributors

Greater Minneapolis-St. Paul Area & Virtual

• Developed, managed, and tracked FDA 483 retrospective remediation review
• Led focus group pilot project, and developed project plan to address CAPA system backlog
• Conducted process assessment and identified opportunities for improvement
• Co-led international MDR TF process review and assisted in consolidating recommendations
• Led international team for virtual mock audits of client, audit simulation sessions, and CAPA content reviews

Greater Minneapolis-St. Paul Area & Paris Suburb

• Launched and led division portion of corporate program across 3 sites, 2 countries, and more than 100 individuals to prepare for new EU Medical Device Regulation.
• Generated program wide SCRUM backlog with statistical tracking to aid with SCRUM implementation and to provide data-based forecasts.
• Led high profile innovation project using visual project management tools

Greater Minneapolis-St. Paul Area

• Led high profile continuous improvement projects and new development projects.
• Connected and guided cross-functional teams, vendor teams, and international colleagues to increase collaboration and bring projects to successful completion.
• Provided informative updates to multiple levels of management through a variety of communication mediums and project tracking measures.

Humlebaek, Denmark

• Led an early technology development project with internal and external partners.
• Generated design history file documentation for new product development.
• Increased connections and knowledge sharing between functional areas and divisions.

Greater Minneapolis-St. Paul Area

• Led the feasibility testing, design documentation, and verification testing for a widespread change of a critical component.
• Generated design control documentation, effectively communicated changes, and streamlined crossfunctional reviews to maintain schedule for understaffed project.
• Quickly adapted to multiple documentation systems to find, assess, and summarize historical information across multiple product lines.

• Conducted characterization testing, formalized test methods, and clarified specifications.
• Wrote protocols, executed testing, and assessed results for design verification and validation of component replacement for cryoablation product line.

Core & Extended Team Member for Source of High Profile Critical ComponentResident Collagen Expert within Cardiovascular Division for internal development of collagen material.Advanced project out of redevelopment cycle by increasing strength of collagen component by 4-fold without negatively impacting other specifications.Planned, executed, and analyzed.

Critical participant in Due Diligence for Datascope Interventional Products Division Acquisition Technical Team Lead for Technology Development Project with Acquired Collagen ProcessesCore and Extended Team Member on Continuous Improvement and New Development ProjectsResident Collagen Expert within Cardiovascular Division for internal development of.

PhD Project Title: Collagen Processing for Tissue-Engineered Cornea StromaAdvisor: Prof. Allison HubelInvestigated multiple fabrication techniques for cellularized collagen sponges and films tooptimize collagen film crosslinking method creating both transparent and strong matrices.

MS Project Title: Multipotent Adult Progenitor Cell Derived Artificial Arteries Advisor: Prof. Robert T. Tranquillo, BME Department HeadDemonstrated proof of principle for coentrapment of MAPC-derived smooth muscle cells andendothelial cells in fibrin around a porous scaffold for tissue-engineered arteries.

Phd, Ms, Biomedical Engineering

PhD Dissertation Titled "Collagen Processing for Tissue-Engineered Corneas: Influence on Optical and Biomechanical Properties." MS Project.

Certified Professional Project Manager (Cppm)

Project Management Certificate

Bs, Chemical Engineering

Minor in Biomedical Engineering Study Abroad: Junior year courses in German at Otto-von-Guericke Universitaet, Magdeburg, Germany.

Education record