David Stephens

About David Stephens

I’m a business development and sales leader with over 20 years of success in the medical device industry, spanning OEMs, contract manufacturers, and global design-to-launch partnerships. Throughout my career, I’ve helped companies bring Class I, II, and medical devices to market by aligning technical strategy with business growth — from initial concept and regulatory pathways to manufacturing scale-up and sustained production.I specialize in building and expanding customer relationships that drive revenue. I\'ve secured multimillion-dollar contracts, managed $100M+ global accounts, and led cross-functional teams across engineering, quality, and operations to deliver scalable solutions. Whether negotiating complex manufacturing and service agreements or guiding a product from concept through commercial launch, I consistently align business strategy with customer success.With proven expertise in FDA/ISO compliance, NPI/NPD, and global operations, I thrive in fast-paced, regulated environments where trust, technical fluency, and long-term value matter. I’m passionate about connecting the dots between customer needs and company capabilities — and turning those connections into sustainable growth.

Experience

1. Global Key Account Manager - Medical

   Invibio

   Oct 2025 — Present · Boulder County, CO, US

   Providing clarity and expert guidance to orthopedic and medical device OEM\'s, helping them navigate complex material choices with a focus on performance, quality, and innovation. As a dedicated account manager for implantable PEEK users, I deliver measurable value through-Insight-driven consultations that align material capabilities with clinical and engineering needs-Focused account management to ensure consistent support and long-term partnerships-Strategic alignment with customer timelines to accelerate product development and market entry-Competitive differentiation through deep knowledge of biomaterials and regulatory landscapesStrategic Business Development Leader | Driving Growth in Medical Devices | OEM/CM Expert | Scaling Medical Device Partnerships | Engineering-Driven Growth | Global Ops & NPI Specialist

Education

• University of North Georgia

  Associate of Science (AS), Engineering Technology, General

  1991 — 1994

• Southern Polytechnic State University

  Bachelor of Science (BS), Mechanical Engineering

  1994 — 1998

Skills

• Design Control
• Solid Modeling
• Validation
• Engineering Management
• Regulatory Submissions
• Project Engineering
• Iso 13485
• Tool Design
• Machine Design
• Mechanical Engineering
• Cardiovascular Devices
• Brachytherapy
• Machine Tools
• Vascular Medicine
• Injection Molding
• Continuous Improvement
• Iso
• Fda
• Product Development
• Medical Device R&D
• Testing
• Cross-Functional Team Leadership
• Machining
• Clinical Trials
• Risk Assessment
• Fmea
• Process Improvement
• Quality System
• Design for Manufacturing
• Engineering
• Product Design
• Root Cause Analysis
• Six Sigma
• Project Management
• Solidworks
• Medical Devices
• Manufacturing
• Team Management
• Management
• Cad