Charles Hwang

About Charles Hwang

As an innovation and product development leader in the medical device industry, I’ve spent over 20 years bringing impactful healthcare technologies to life—from early-stage concept through global commercialization. My work has spanned surgical robotics, wearable drug delivery, combination products, and safety syringes, with a strong focus on human factors engineering (HFE), user-centered design, and cross-functional collaboration.I’ve led initiatives that deliver results: from developing a 120M+ units/year syringe platform to filing over 80 U.S. patents, including IP that helped secure funding for a medical startup. Whether I’m translating clinical workflows into actionable product requirements or facilitating ideation sessions with surgeons and engineers, I bridge strategy and execution with a user-first mindset.My experience includes managing global product teams across the U.S, Spain, and Singapore, leading design for manufacturing (DFM), usability testing (IEC 62366, ISO 14971), and risk analysis for regulated devices. I’ve worked at both Fortune 500 companies and startup labs—always focused on aligning innovation with clinical needs and regulatory realities.With advanced degrees in biomedical engineering, industrial design, and an MBA, I combine deep technical fluency with a strategic, business-oriented perspective. I’m passionate about mentoring teams, advancing healthcare innovation, and solving complex problems that improve patient and provider experiences.If you\'re looking for a collaborative, high-impact leader in medical device innovation, usability, and product strategy, I’d love to connect.

Experience

1. Principal Mechanical Engineer

   Insulet Corporation

   Jan 2026 — Present · Acton, MA, US

   Leading next generation pump innovations, from ideation through proof of concept and transfer to commercialization.

Education

• The Ohio State University

  Master of Science - MS, Biomedical Engineering

  1991 — 1994

• Babson F.W. Olin Graduate School of Business

  Master of Business Administration - MBA, Entrepreneurship

  2009 — 2012

• Pratt Institute

  Master of Industrial Design - MID

  1995 — 1997

• The Ohio State University

  Bachelor of Science - BS, Industrial & Systems Engineering

  1986 — 1991

Skills

• Injection Molding
• V&V
• Patents
• Design Control
• Commercialization
• Iso 13485
• Product Management
• Fda
• Biomedical Engineering
• Testing
• Cad
• Product Design
• Failure Mode and Effects Analysis (Fmea)
• Strategic Planning
• Surgical Instruments
• Validation
• Solidworks
• Management
• Patent Law
• Product Launch
• Industrial Design
• Research and Development (R&D)
• Computer-Aided Design (Cad)
• Fmea
• Product Development
• Analysis
• R&D
• U.s. Food and Drug Administration (Fda)
• Design of Experiments
• Manufacturing
• Verification and Validation (V&V)
• Medical Devices
• Design for Manufacturing
• Cross-Functional Team Leadership