Alexander Schreiber

Director Project Management | Medical Device R&D | FDA 21 CFR Part 820 & ISO 13485 | US & China Market | Design Assurance | Global Teams

Tann, Hesse, Germany

About

Experienced Director Project Manager in Medical Device R&D, leading international development projects from concept to production. Skilled in FDA 21 CFR Part 820, ISO 13485, Design Assurance, and Design Control. Proven track record of delivering compliant, market-ready solutions for the U.S. and Chinese markets. Strong communicator and team leader, managing global cross-functional teams in highly regulated environments. ✅ Expertise: • Medical Device Development • Regulatory & Quality Compliance • US & China Market Integration • Cross-functional Leadership • Risk & Design Control

Experience

  • Fresenius Medical Care (7 yrs 5 mos)
    • Director Engineering Project Management
      Mar 2026 - Present · 4 mos

    • Senior Engineering Project Manager
      Nov 2024 - Mar 2026 · 1 yr 5 mos

    • Senior Manager Design Quality Assurance
      Oct 2023 - Feb 2025 · 1 yr 5 mos

      Responsible for Product Design Quality for Active Medical Device within the vertical In-Center Leading a global team with Design Quality Experts

  • Ondal Medical Systems GmbH (Full-time · 4 yrs 10 mos)
    • Projektleiter Produktentwicklung
      Mar 2017 - Jan 2019 · 1 yr 11 mos

      Project management in an international MedTech environment Planning and control of projects for new development of innovative mechanical and electromechanical carrier systems Responsibility for all phases of the product development process: from the product idea through conception and to final series production Responsibility for compliance with project goals Leadership and motivation of the project team

    • Design Change Responsible / Design Change Control Coordinator
      Apr 2014 - Feb 2017 · 2 yrs 11 mos

      Managing the daily business of the change management Project lead of high-level change projects Responsible for the improvement of the related change processes

  • Zeitsoldat at German Air Force
    Jul 2003 - Oct 2010 · 7 yrs 4 mos

    Aviation Electronics