Skills
Experience
Staff Product Development Engineer
ACell, Inc. (now Integra Lifesciences)
April 2022 – Present
Columbia, MD
- ·Lead medical device development projects from concept through FDA approval and commercial launch.
- ·Manage cross-functional project teams and participate in Franchise teams.
- ·Prepare Special and Traditional 510(k) submissions to the FDA.
- ·Prepare risk assessments, evaluation plans, gap analyses, and reports in compliance with ISO 10993 and ISO 14971.
- ·Design experiments, validate test methods, and qualify equipment and processes including packaging validation, design verification and validation, shelf life studies, and pre-clinical studies.
- ·Test products to ISO 10993 (Biocompatibility), ISO 11137 (Sterilization), and IEC 62366 (Usability) standards.
- ·Author protocols, reports, and standard operating procedures.
- ·Prepare project budgets, timelines, and business cases.
Senior Product Development Engineer
ACell, Inc.
January 2020 – April 2022
Columbia, MD
- ·Advanced medical device projects through the product development lifecycle.
- ·Led design control activities including voice of customer, test method validation, and regulatory documentation.
- ·Contributed to 510(k) submissions and biocompatibility evaluation plans.
Product Development Engineer
ACell, Inc.
June 2017 – December 2019
Columbia, MD
- ·Executed design verification and validation studies for Class II medical devices.
- ·Authored technical reports and standard operating procedures.
- ·Supported FDA regulatory submissions and pre-clinical study coordination.
Postdoctoral Associate
University of Pittsburgh — McGowan Institute for Regenerative Medicine
June 2015 – May 2017
Pittsburgh, PA
- ·Conducted research in the Laboratory of Stephen F. Badylak on extracellular matrix (ECM) bioscaffolds and regenerative medicine.
- ·Served as liaison and project lead for four commercial collaborations and multiple independent research projects.
- ·Investigated wound healing, innate immunity, macrophage characterization and polarization, and bone regeneration models.
- ·Wrote original research papers, reviews, book chapters, materials transfer agreements, and grants.
- ·Mentored PhD students, undergraduate researchers, and high school students.
- ·Presented research at national conferences.
Research Assistant
Tulane University School of Medicine — Center for Stem Cell Research
August 2010 – May 2015
New Orleans, LA
- ·Conducted doctoral research in the Laboratory of Bruce A. Bunnell on lung tissue engineering, lung bioreactors, and stem and endothelial cell biology.
- ·Managed project teams and cross-functional collaborations.
- ·Mentored medical students, PhD students, and supervised individual research projects.
- ·Wrote original research papers and reviews; presented at internal and external conferences.
- ·Research areas included organ/tissue decellularization and recellularization (liver and trachea), bioreactor design, iPSC polarization and culture, hepatocyte isolation, and fluorescence-activated cell sorting.
Teaching Assistant
Tulane University
August 2010 – December 2011
New Orleans, LA
- ·Taught Molecular Biology Laboratory and graded for Biochemistry.
Summer Research Fellow
Tulane National Primate Research Center
June 2009 – August 2009
New Orleans, LA
- ·Investigated the use of mesenchymal stem cells as a treatment for globoid cell leukodystrophy.
- ·Presented research at the 2009 TNPRC Summer Research Symposium.
Education
PhD in Biomedical Sciences (GPA 4.0)
Tulane University School of Medicine
New Orleans, LA
August 2010 – May 2015
Doctoral thesis on lung tissue engineering, lung bioreactors, and stem and endothelial cell biology. Selected honors: Caroline tum Suden/Frances A. Hellebrandt Professional Opportunity Award (APS, 2011); Tulane Health Sciences Research Days Award — Stem Cell Research and Regenerative Medicine (2012); Tulane Health Sciences Research Days Award — Excellence in Research and Presentation (2013).
Bachelor of Science in Biochemistry (GPA 3.9) — Summa Cum Laude with Honors
Florida State University
Tallahassee, FL
August 2007 – May 2010
Member of Golden Key International Honour Society, National Society of Collegiate Scholars, and Phi Eta Sigma National Honors Society.
Certifications
Project Management Professional (PMP)
Project Management Institute
Medical Device Project and Team Manager
Industry Certification
Design Control Requirements — Integrating the Quality System Regulation
AAMI
Biocompatibility of Medical Devices (ISO 10993)
NAMSA Laboratories
Publications
Re-endothelialization of Rat Lung Through Passive, Gravity-driven Seeding of Segment-Specific Pulmonary Endothelial Cells
Scarritt ME, Pashos NC, Motherwell JM, Eagle ZR, Burkett BJ, Gregory AN, Mostany R, Weiss DJ, Alvarez DF, Bunnell BA.
Organ engineering: Promise, progress, and prospective
Scarritt M, Badylak SF.
Hypertensive Rat Lungs Retain Hallmarks of Vascular Disease Upon Decellularization but Support the Growth of Mesenchymal Stem Cells
Scarritt ME, Bonvillain RW, Burkett BJ, Wang G, Glotser EY, Zhang Q, Sammarco MC, Betancourt AM, Sullivan DE, Bunnell BA.
A Nonhuman Primate Model of Lung Regeneration: Detergent-Mediated Decellularization and Initial In Vitro Recellularization with Mesenchymal Stem Cells
Bonvillain RW, Danchuk S, Sullivan DE, Betancourt AM, Semon JA, Eagle ME, Mayeux JP, Gregory AN, Wang G, Townley IK, Borg ZD, Weiss DJ, Bunnell BA.
Mesenchymal-lineage stem cells have pronounced anti-inflammatory effects in the twitcher mouse model of Krabbe's disease
Ripoll C, Flaat M, Eiermann J, Perkins J, Trygg C, Scruggs B, McCants M, Leonard H, Lin A, Zhang S, Eagle M, Alvarez X, Li Y, Li S, Gimble J, Bunnell B.