Profileimage by Stefan Schmidt Senior Expert/Consultant Medical Devices from Overath

Stefan Schmidt

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Last update: 19.03.2021

Senior Expert/Consultant Medical Devices

Graduation: PhD in Physics
Hourly-/Daily rates: show
depending on project conditions
Languages: German (Native or Bilingual) | English (Full Professional) | French (Elementary)

Attachments

CV S. Schmidt.pdf

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
New proton therapy (PT) facility project in Tianjin, China - Head of Systems Engineering and Physics and Senior Scientist
Schaer Proton AG (10-50 employees)
Pharmaceuticals and medical technology

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
Development of a new compact PT product line - Overall Technical Lead
Varian Medical Systems PT GmbH (250-500 employees)
Pharmaceuticals and medical technology

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
Introduction of improved PT system architecture - Overall System Architect
Varian Medical Systems PT GmbH (250-500 employees)
Pharmaceuticals and medical technology

Major achievements:

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

  • Evaluated and introduced new system architecture concept and methods.


10/2015 - 07/2017
Particle therapy product and roadmap definition - Product Manager
Varian Medical Systems PT GmbH (250-500 employees)
Pharmaceuticals and medical technology

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
Tender process management
Varian Medical Systems PT GmbH (250-500 employees)
Pharmaceuticals and medical technology

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
Implementation of new Risk Management process
Ondal Medical Systems GmbH (250-500 employees)
Pharmaceuticals and medical technology

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
Development of a superconducting fault current limiter - Project Manager
Bruker Advanced Supercon GmbH (50-250 employees)
Industry and mechanical engineering

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
Productization of proton therapy system - Line Manager
Varian Medical Systems PT GmbH (50-250 employees)
Pharmaceuticals and medical technology

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
RPTC proton therapy facility in Munich - Manager Subprojects and V&V
Accel Instruments GmbH (50-250 employees)
Pharmaceuticals and medical technology

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

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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