Chris Roth

About Chris Roth

Medical Device leader with 22 years of broad experience across multiple disciplines and industries including design and manufacturing, quality and quality systems, for medial devices, defense, and consumer based products. Passion for building high function teams with emphasis on process and personal relationship development is evident to those with whom I have worked.

Experience

1. Director of Engineering Services

   Apollo Endosurgery

   Dec 2015 — Present · Austin, TX, US

   Reporting directly to the EVP of OperationsChris directs and implements company strategy for product manufacturing, manufacturing engineering, quality engineering, and supplier quality functions at Apollo Endosurgery. With 8 FTE direct reports and numerous contractors, Chris oversees collaborative support of 4 Apollo national and international facilities to achieve product launch and stabilization objectives including cost, quality, and capacity targets. Responsible for ensuring Apollo products meet all specifications and quality standards including quality control, documentation, test, review and inspection. Direct management of contract manufacturing sites engaged in the production of Apollo’s products.Additional responsibilities include:Design for Manufacturing enhancementsOversight of sterilization processes including Ethylene Oxide, Dry Heat, Gamma.Supplier Relation management

Education

• Texas A&M University

  Bachelor of Science (B.S.), Mechanical Engineering

  1996 — 2001

Skills

• Manufacturing Engineering
• Medical Devices
• Capa
• Product Development
• Verification
• Iso 13485
• Fda
• Design Control
• Cross-Functional Team Leadership
• Iso 14971
• Design for Manufacturing
• Validation
• Manufacturing
• Quality System
• Engineering
• Statistical Analysis Tools