Shane Lacy

About Shane Lacy

Goals: Interested in medical device and/or biologics opportunities that focus on growing and commercializing highly impactful medical technology. I would like to focus on managment positions related to R&D strategy development and execution as well as product development. Experience: 30 years of experience in medical device/biologics research and development. I have a strong track record in medical device opportunity identification, new business development, feasibility research studies, development and commercialization and Organizational talent management and development. I have Managed various synthetic sealant & scaffolds and biologic-oriented projects throughout a new product development process and Supervised and developed full time R&D associates as well as R&D contractors for key projects. I have Designed and directed preclinical, research & product development projects in synthetic sealants, tissue scaffolds, tissue regeneration, spine orthopedics, nucleus replacement, and orthobiologics and Managed preclinical studies that were conducted to demonstrate feasibility, identified/reduced development risks, and facilitated the transition of product to human clinical studies. I have provided scientific technical support and oversight for preparation of preclinical sections of regulatory submissions and responded to related questions and Acted as expert resource to the executive management team on strategic development of new In Vivo and In Vitro studies as well as new business development ventures.Specialties: Medical Device Research & Development, Project Leadership & Management, Design Control, Biomaterials, Biomechanics, Bicompatibility, Preclinical & Clinical Studies, Tissue Engineering, Biomedical Engineering (In Vitro, Ex Vivo, and In Vivo) Preclinical Model Development, Adhesives and Sealants, New Business Development, People Management and Development and Biodesign

Experience

1. Associate Director, Global Product Stability Compliance and Science, Surgery R & d

   Johnson & Johnson MedTech

   Jul 2025 — Present · Raritan, NJ, US

   Associate Director, Global Product Stability Compliance and Science, Surgery R&D at Johnson & Johnson MedTech.

Education

• Case Western Reserve University

  BS, Biomedical Engineering (Biomaterials)

  1989 — 1993

• University of Alabama at Birmingham

  MS, Biomedical Engineering (Biomaterials, Biomechanics & Biocompatibility)

  1993 — 1996

Skills

• Medical Devices
• Clinical Research
• Capa
• Biomedical Engineering
• Gmp
• Start-Ups
• In Vitro
• Verification and Validation (V&V)
• Design Control
• Polymers
• Cross-Functional Team Leadership
• Biomaterials
• Product Development
• Technology Transfer
• Biomechanics
• Cell
• Validation
• Orthopedics
• Fda
• Strategic Planning
• Cell Biology
• Testing
• New Business Development
• Commercialization
• Biotechnology
• Stem Cells
• Research and Development (R&D)
• R&D
• U.s. Food and Drug Administration (Fda)
• Tissue Engineering
• Quality System
• Molecular Biology
• Product Launch
• Iso 13485
• Assay Development
• Spine
• Surgery
• Laboratory
• Research
• 510 K