Dave Hinds

About Dave Hinds

Experienced and results-driven senior medical executive with a proven track record in developing and implementing strategies that drive operational efficiency, sales growth and positive patient outcomes. Diverse background spanning operations, regulatory compliance, engineering and IT team leadership. Recognized as an effective leader, motivator, communicator and collaborative partner across multidisciplinary teams. Cultivator of high-performing teams, focusing on personal and professional achievement.

Experience

1. VP of Product Commercialization and Regulatory Affairs

   Us Medical Innovations, Llc

   Apr 2018 — Present · Takoma Park, MD, US

   Oversee commercialization operations for a $4M dollar medical device business.• Product Regulatory Certification: Responsible for maintaining ISO 134895:2016, ISO 9001 and CE Certification for two companies. Facilitate internal, external BSI, FDA audits and annual Risk Management activities. Maintain electrical regulatory certification for entire product portfolio. • Hosted over 30 successful quality audits covering ISO 13485, 9001, Sterility/Microbiology, CE/MDD and FDA). Performed CAPA remediation, Post Market Surveillance, Supplier Prep, Training, Design Transfer.• Product Regulatory FDA 510(k): Submission for the Canady Plasma Electrosurgical Generator, Canady Helios Cold Plasma Ablation System and the Canady Flex Robowrist.• Acquisition Support: Key regulatory and operational manager for acquired French company (Endocontrol) supporting CE certified class 2 robotic medical devices.• Business Development: Key team member designing displays, demonstrating products and meeting with surgeons at global medical tradeshows including American College of Surgeons, Medica, and Arab Health. Represented USMI at Global Partnering events including the Maryland Department of Commerce Export India. • Vendor Management: Create and manage quality agreements with key vendors for sterilization and manufacturing operations.

Education

• Princeton University

  MSEE, Electrical Engineering, Digital Signal Processing

  1986 — 1991

• University of Delaware

  BSEE, Electrical Engineering

  1986 — 1990

Skills

• Software Development
• Voip
• Testing
• Business Analysis
• Telecommunications
• Avaya
• Vendor Management
• Business Process
• Integration
• Cross-Functional Team Leadership
• Product Management
• Sip
• Solution Architecture
• Saas
• Solution Selling
• Product Lifecycle Management
• Engineering
• R&D
• Telephony
• Configuration Management
• Information Technology
• Unified Communications
• Wireless
• Ip
• Pre-Sales
• Professional Services
• Avaya Technologies
• IT Operations
• Sap Erp
• Web Development
• Software Engineering
• Program Management
• Enterprise Software
• Management
• Process Improvement
• Agile Methodologies
• Strategy
• Strategic Planning
• System Deployment
• Sdlc