Bulent Bayraktar

About Bulent Bayraktar

More than 15 years of experience on product development and project management with FDA Class II and Class medical devices.• An excellent track record of increasing responsibilities towards on-time delivery of quality and compliant new products as well as incremental releases for install-base/on-market products.• Goal-oriented and champion of multi-tasking with excellent team player and leadership qualities.• Ability to work in a highly matrixed and geographically diverse business environment.• Ability to work within a team in a fast-paced and changing environment.• Ability to effectively integrate information from various disciplines including Marketing, Program Management, Research & Development, Clinical Science/Affairs, Quality Assurance, and Regulatory Affairs.• I foster collaboration with cross-functional teams globally; system, subsystem and other platform leaders to drive work to completion.• I resolve competing constraints between interrelated functions (marketing, engineering, manufacturing, regulatory, quality, etc.) required to deliver the product to market.• I successfully influence stakeholders and communicate effectively with direct reports, peers, managers, and senior management.Specialties and Core Competences:• Product Development Lifecycle• New Product Introduction• Systems Engineering and related tools (DOORS, HP Quality Center)• Project Management• Install-base/On-Market product support projects• Risk Management• Functional management• Post-Market Surveillance• Internal and External Audits• Human Factors and Usability• Verification and Validation (V&V)• Regulations and Standards: 21 CFR 820.30 (Design Controls), ISO 13485 (Medical Devices Quality Management System), ISO 14971 (Medical Devices Risk Management), IEC 62366-1 (Medical Devices Usability Engineering), IEC 60601-1 (Medical electrical equipment - Basic Safety and Essential Performance), IEC 62304 (Medical Devices SW Lifecycle).

Experience

1. Director, Capability Deployment Manager

   Philips

   Jul 2021 — Present · US

   Innovation & Strategy / Innovation Effectiveness

Education

• Case Western Reserve University

  B.S., Electrical Engineering and Applied Physics

  1994 — 1998

• Case Western Reserve University

  M.S., Electrical Engineering and Applied Physics

  1998 — 1999

• Purdue University

  Ph.D., Electrical and Computer Engineering

  1999 — 2006