Stefan Schmidt partly available

Stefan Schmidt

Senior Expert/Consultant Medical Devices

partly available
Profileimage by Stefan Schmidt Senior Expert/Consultant Medical Devices from Overath
  • 51491 Overath Freelancer in
  • Graduation: PhD in Physics
  • Hourly-/Daily rates:
  • Languages: German (Native or Bilingual) | English (Full Professional) | French (Elementary)
  • Last update: 19.03.2021
KEYWORDS
PROFILE PICTURE
Profileimage by Stefan Schmidt Senior Expert/Consultant Medical Devices from Overath
ATTACHMENTS
CV available on request

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SKILLS
  • Medical Devices and Development Processes:
    Medical Device Directive (MDD, 93/42/EEC), Medical Device Regulation (MDR, regulation (EU) 217/745), ISO 13485, 21 CFR 820 (quality management), IEC 60601 series (medical electrical devices), IEC 62304 (medical software), ISO 14971 (risk management), IEC 62366 (usability), medical-device registration/certification processes (CE, FDA, NMPA), requirements management, verification & validation, configuration management, change management, systems engineering, system architecture
  • Project Management
  • Product Management
  • Team Management
  • Technical Skills:
    Radiation therapy and related techniques (dosimetry, imaging, patient positioning, control systems, treatment planning, ...), particle accelerators, accelerator physics, beamline magnets, superconductors, cryogenics
     
PROJECT HISTORY
  • 11/2018 - 07/2020

    • Schaer Proton AG
    • 10-50 employees
    • Pharmaceuticals and medical technology
  • New proton therapy (PT) facility project in Tianjin, China - Head of Systems Engineering and Physics and Senior Scientist
  • Company and team build-up support and PT system development activities for Schaer Proton as head of systems engineering and senior scientist

    Major achievements:

    • Adapted engineering processes to cover full particle therapy systems.

    • Strongly affected set-up of RA/QM processes.

    • Effected and strongly contributed to overall project task and resource planning.

    • Effected and strongly contributed to hiring of engineering, RA and QM key resources.

    • Introduced layout of overall system architecture.

    • Introduced requirements tracing process and implemented according tools.

    • Defined technical documentation structure.


  • 08/2017 - 10/2018

    • Varian Medical Systems PT GmbH
    • 250-500 employees
    • Pharmaceuticals and medical technology
  • Development of a new compact PT product line - Overall Technical Lead
  • Major achievements:

    • Managed technical alignment between multi-national teams.

    • Finalized major system design activities for new compact proton therapy system.

    • Ensured compliance with medical-device standards and regulations.


  • 08/2017 - 10/2018

    • Varian Medical Systems PT GmbH
    • 250-500 employees
    • Pharmaceuticals and medical technology
  • Introduction of improved PT system architecture - Overall System Architect
  • Major achievements:

    • Set up team of 10 multi-disciplinary system architects.

    • Evaluated and introduced new system architecture concept and methods.


  • 10/2015 - 07/2017

    • Varian Medical Systems PT GmbH
    • 250-500 employees
    • Pharmaceuticals and medical technology
  • Particle therapy product and roadmap definition - Product Manager
  • Market monitoring, introduction of new product features, and research coordination for Varian Medical Systems as PT product manager

    Major achievements:

    • Implemented new product requirements and use cases.

    • Conducted product review surveys with worldwide customers.

    • Introduced new product features and development activities into product roadmap.

    • Drove collaborative activities with research institutes.


  • 05/2014 - 09/2015

    • Varian Medical Systems PT GmbH
    • 250-500 employees
    • Pharmaceuticals and medical technology
  • Tender process management
  • Major achievements:

    • Contributed significantly to winning of 4 new sales contracts.

    • Actively participated in dialogue sessions with potential new customers.

    • Introduced database for tender/RFP responses.

    • Generated tender response documents.


  • 12/2013 - 04/2014

    • Ondal Medical Systems GmbH
    • 250-500 employees
    • Pharmaceuticals and medical technology
  • Implementation of new Risk Management process
  • Major achievements:

    • Introduced new risk management process complying with updated normative requirements (EN 14971, EN 60601-1, 2nd and 3rd edition).

    • Trained team in new process.


  • 05/2010 - 11/2013

    • Bruker Advanced Supercon GmbH
    • 50-250 employees
    • Industry and mechanical engineering
  • Development of a superconducting fault current limiter - Project Manager
  • Major achievements:

    • Secured public funding.

    • Managed multi-company team.

    • Realized major project milestones (until shut-down of whole business unit for strategic reasons).


  • 10/2007 - 04/2010

    • Varian Medical Systems PT GmbH
    • 50-250 employees
    • Pharmaceuticals and medical technology
  • Productization of proton therapy system - Line Manager
  • Major achievements:

    • Implemented business line “Treatment Delivery Systems and Systems Engineering” and team (particle therapy)

    • Updated proton therapy system design to enable a transition from a project approach to a product approach.

    • Drove adaptation of Engineering processes and full update of proton therapy product and system requirements.

    • Ensured compliance with medical-device standards and regulations.


  • 03/2002 - 09/2007

    • Accel Instruments GmbH
    • 50-250 employees
    • Pharmaceuticals and medical technology
  • RPTC proton therapy facility in Munich - Manager Subprojects and V&V
  • Major achievements:

    • Established overall work break-down structure and large fractions of project planning.

    • Established system requirements.

    • Established engineering processes.

    • Significantly contributed to set-up of QA and regulatory environment and to generation and technical documentation for medical-device certification.

    • Successfully drove development, fabrication, installation and commissioning of proton therapy subsystems (scanning system, gantries, patient tables, image guidance systems)

    • Successfully conducted system verification and validation.

    • Strongly contributed to sales activities.


  • 04/1997 - 02/2002

    • Ion Beam Applications SA
    • 50-250 employees
    • Pharmaceuticals and medical technology
  • NPTC/FHBPTC proton therapy facility at MGH, Boston - Technical Representative and Team Lead
  • Major achievements:

    • Conducted tests enabling qualification of gantry (major proton therapy component) for shipment to customer site.

    • Generated installation and commissioning plan.

    • Significantly contributed to installation and commissioning activities.

    • Performed design calculations for 2nd type of double-scattering nozzles (major proton therapy component).

    • Contributed to RA/QM processes.


TIME AND SPATIAL FLEXIBILITY
All European projects are considered.
Maximum availability is 35 hours per week (may be more in peek situations).
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