Eric Klumper
A good partner wants to understand your market, your users, your business model, and your timeline before they ever talk about solutions.
Eric Klumper
About Eric
With over 16 years of hands-on experience in medical device design and engineering, Eric has built a career around one principle: great devices are born from precision and fearless iteration.
A veteran of Olympus, Terumo BCT, and Bolder Surgical, Eric specializes in bridging the ‘Valley of Death’ between prototype and production.
He successfully secured IDE and Post-Approval Study (PAS) clearance for critical blood processing systems and has led the commercialization of over 10 Class II medical devices.
His focus is on Design Transfer and Process Validation (IQ/OQ/PQ), ensuring manufacturability is baked in from Day One.
Core Competencies
Development
Concept Feasibility,
Rapid Prototyping,
Design Controls (DHF)
Manufacturing
Supply Chain Mgmt,
Scale-Up Logic.
Systems
- ISO 13485 QMS Implementation,
- Risk Mgmt (ISO 14971).
Education & Experience
Education
- B.S. Biomedical Engineering (Biomechanics) — University of Akron
Certifications
- Lean Design (Munro & Assoc)
- Injection Mold Design (Penn State)
Experience
Finite Element Analysis (FEA), SolidWorks, 5-Axis CNC
