Paul Wingelaar

Chief Technology Officer at Bambi Medical

Lommel, Flemish Region, Belgium

About

Technology executive with a proven track record in scaling multidisciplinary R&D organizations and delivering complex, regulated products from concept to market. Experienced in leading end-to-end innovation across medical devices, high-tech systems, and electrochemical engineering. Combines deep technical expertise with strategic execution, translating customer and regulatory requirements into scalable product architectures. Recognized for building high-performing teams, transforming organizations, and consistently delivering first-time-right solutions in highly regulated environments.

Experience

  • Bambi Medical (Eindhoven, North Brabant, Netherlands · On-site)
    • Chief Technology Officer
      Aug 2022 - Present · 3 yrs 11 mos

      Full executive responsibility for technology strategy, product development, and regulatory compliance of a Class II medical device portfolio. Key achievements: • Led the successful development and CE certification of a Class IIb medical device under MDR (DNV), positioning the company among early adopters in the Netherlands • Delivered a Class IIa product from concept to market approval within 18 months, establishing a repeatable development and regulatory framework • Defined and implemented the system architecture across mechanics, electronics, and software • Built and led a multidisciplinary development ecosystem (internal team + external partners) • Translated clinical feedback into product roadmap and continuous design improvements • Acted as system architect, ensuring compliance with IEC 60601, ISO 14971, and IEC 62304

    • Systems manager (Acting CTO)
      Feb 2021 - Sep 2022 · 1 yr 8 mos

      Responsible for system architecture and technical leadership of a Class IIb medical device platform. Key achievements: • Restructured requirements engineering to achieve full compliance with MDR and applicable standards • Established end-to-end risk management framework according to ISO 14971 • Delivered first-time-right compliance on safety, performance, and EMC • Completed full technical documentation for successful notified body review

  • Philips (6 yrs 2 mos)
    • Director Of Innovation
      Mar 2020 - Feb 2021 · 1 yr

      Led end-to-end innovation and product development for the Philips Lumea IPL portfolio. Key achievements: • Transformed the R&D organization into a lean, platform-based structure (single PDLM model with cross-functional squads) • Transitioned the product portfolio from consumer electronics to regulated medical devices (Class IIb) • Established missing core capabilities (Test & Verification, Customer Insights), enabling full end-to-end development ownership • Defined long-term innovation roadmap in close collaboration with commercial leadership

    • Department Manager Hardware (Electronics)
      Jun 2017 - Mar 2020 · 2 yrs 10 mos

      I am responsible for the resources (26 FTE) of the Electronics department (NPI & PQ&M) with the focus on • electromagnetic compatibility • hardware infrastructure • power infrastructure • motion infrastructure.

    • Product Owner Hardware Infrastructure
      Oct 2016 - Dec 2018 · 2 yrs 3 mos

      Main responsibilities: • Lead the hardware infrastructure cluster team of the fixed X-Ray (IGT) system • Lead the transformation from “Cabinet and cabling cluster” to “Hardware infrastructure cluster”

  • Electronics architect at YER
    Jan 2015 - Apr 2016 · 1 yr 4 mos

    Employed at Philips as Electrical Designer .

  • Electronics Architect / Sr. Electronics Engineer at Demcon
    Sep 2012 - Dec 2014 · 2 yrs 4 mos

    Main responsibilities: • Team lead electrical and software group Demcon South • Electronics architecture of high-tech projects • Software designer high-tech projects

  • DutchAero BV (Brabantine City Row)
    • Manager Advanced Technologies & ECM Specialist
      Nov 2010 - Sep 2012 · 1 yr 11 mos

      Main responsibilities: • Lead the R&D team (MT member) • Electrochemical Machining specialist (research lead) • Intellectual Properties • Technology roadmap

    • Cell leader thermal spray (interim 2-3 months)
      Mar 2012 - Jun 2012 · 4 mos

      Main responsibilities: • Production Thermal Spray (12FTE) • Coating evaluation laboratory (2FTE)

    • ECM Specialist
      Sep 2007 - Nov 2010 · 3 yrs 3 mos

      Main responsibilities: • Research leader Electrochemical Machining • Project lead R&D Blisk projects (project lead) • Multidisciplinary designer (mechanical, electrical, chemical & software)