Erik Hartholt

Background

About Erik Hartholt

Director of Operations & R&D Manager | Semiconductor & Medical Device Expert | ISO13485 | Sensor Technologies | From Concept to Market 🧭 About Director of Operations and R&D Manager with extensive experience in the semiconductor and medical device industries. Proven track record in leading multidisciplinary teams from concept through development, validation, and production transfer. Strong focus on innovation, quality, and operational excellence under ISO13485 standards. Skilled in semiconductor and MEMS sensor technologies, medical device engineering, and system integration. Experienced in R&D leadership, failure analysis (FMEA), and industrialization of complex products. Passionate about translating advanced technology into reliable solutions that improve human health, animal welfare, and environmental sustainability. Core Expertise: R&D Leadership • ISO13485 • Semiconductor & MEMS Sensors • Medical Device Development • Product Industrialization • FMEA • Cross-Functional Team Leadership • Operations Management Selected Achievements: SmartPill: Capsule for full GI-tract analysis, measuring pH, temperature, and pressure; led design, validation, and production transfer. FFR Catheter: Integrated MEMS pressure sensors for advanced cardiovascular diagnostics. HRM Catheter: Developed a high-resolution manometry catheter with a custom communication protocol. Urodynamic Catheter: Designed a precision catheter for pressure and flow monitoring in urodynamic applications. CowPill: Created a capsule for continuous pH monitoring in ruminants, improving livestock health insights. Environmental Probe: Engineered a durable water quality monitoring system for long-term deployment. IVF pH System: Developed a precision pH measurement solution for in-vitro fertilization applications. Most projects successfully reached the market, reflecting technical excellence, regulatory compliance, and sustained performance. Committed to developing technologies that bridge research, reliability, and real-world impact.