extensive experience in engineering and 3D modelling. experience obtained in the medical field.

Gerhard van Wolfswinkel

extensive experience in engineering and 3D modelling. experience obtained in the medical field.

Available to hire

extensive experience in engineering and 3D modelling. experience obtained in the medical field.

Language

Dutch
Fluent
English
Fluent
German
Intermediate

Work Experience

Global Manager Product and Irradiation Engineering, Interventional Oncology at Quirem Medical, a Terumo NV company
March 1, 2021 - Present
Lead design and development of Class III medical devices for administration of medical isotopes (concept engineering, prototyping disposable and reusable devices, clinical investigations with KOLs). Oversee process engineering for hotlab manufacturing (requirements, prototyping, pFMEA, verification/validation) and stakeholder management. Drive usability engineering including interviews and treatment observations per IEC 62366 and ISO 14971. Conduct hands-on in-vitro and ex-vivo research with academic partners. Responsible for irradiation process development at nuclear facilities worldwide, including feasibility/test plan design and verification/validation.
Manager PMO & Reactor operations at Quirem Medical (start-up company)
February 28, 2021 - October 7, 2025
Implemented project management and portfolio management approaches, established change control, led the PMO team (2 FTE), and contributed to irradiation process development.
Technical Support Officer at Quirem Medical (start-up company)
September 30, 2018 - October 7, 2025
Worked on clinical research projects in interventional oncology; developed simulation models to analyze clinical treatment methods with European academic hospitals; led process optimization and verification/validation in accordance with ISO 13485.
Mechanical Engineer at Hop Fencingsystems
December 31, 2011 - October 7, 2025
Custom design and development of electro/mechanical fencing systems and constructions.
Internship at Orthopaedic Research Department, Academisch Medisch Centrum (AMC), Amsterdam
December 31, 2015 - October 7, 2025
Assistance during courses for orthopaedic surgeons (Amsterdam Foot and Ankle Course); OR experience including total knee replacement surgery.
Global Manager Product and irradiation Engineering, Interventional Oncology at Quirem Medical, a Terumo NV company
March 1, 2021 - Present
Design and development of medical devices (Class III) for administration of medical isotopes; concept engineering, prototyping disposable and reusable devices, and clinical investigations in collaboration with KOLs. Process engineering for hot-lab manufacturing; usability engineering; hands-on research (in-vitro and ex-vivo); responsible for irradiation process development at nuclear facilities worldwide; feasibility tests and research plan design; verification and validation; stakeholder management.
Manager PMO & Reactor operations at Quirem Medical
February 1, 2021 - October 7, 2025
Implementation of a project management and portfolio management approach; change control management; leading the project managers team (2 FTE); irradiation process development.
Technical Support Officer at Quirem Medical
September 1, 2018 - October 7, 2025
Clinical research projects in interventional oncology; development of simulation models to analyse clinical treatment methods in collaboration with European academic hospitals; process optimisation, verification and validation in accordance with ISO 13485.
Graduation Project at TNO Industrie & Techniek, Delft
January 1, 2009 - October 7, 2025
Development of an innovative mechanism for minimally invasive instruments with haptic feedback; prototype design and testing.
Mechanical Engineer at Hop Fencingsystems, Barneveld
January 1, 2011 - October 7, 2025
(Custom) design and development of electro/mechanical fencing systems and constructions.
Internship - Orthopaedic Research Department at Academisch Medisch Centrum (AMC), Amsterdam
January 1, 2015 - October 7, 2025
Assistance during courses for orthopaedic surgeons; OR experience; total knee replacement surgery.

Education

Master Biomedical Engineering (WO, MSc) at Technische Universiteit Delft
January 1, 2013 - January 1, 2016
Bachelor Mechanical Engineering (HBO, BEng) at Christelijke Hogeschool Windesheim, Zwolle (HTS)
January 1, 2006 - January 1, 2009
Intermediate technical school, Mechanical engineering (MTS) at Hoornbeeck college, Amersfoort
January 1, 2002 - January 1, 2006
Master Biomedical Engineering (MSc) at Technische Universiteit Delft
January 1, 2013 - January 1, 2016
Bachelor Mechanical Engineering (BEng, HBO) at Christelijke Hogeschool Windesheim, Zwolle
January 1, 2006 - January 1, 2009
Intermediate technical school, Mechanical engineering (MTS) at Hoornbeeck College, Amersfoort
January 1, 2002 - January 1, 2006

Qualifications

Stralingsbescherming TMS -VRS -D (radiation protection level 5B)
January 11, 2030 - October 7, 2025
CE Certification of Your Medical Device
January 11, 2030 - October 7, 2025
Prince2 Certified Foundation & Practitioner
January 11, 2030 - October 7, 2025
Introduction to Quality management for Medical devices and ISO 13485
January 11, 2030 - October 7, 2025
Introduction Design Control Medical Devices
January 11, 2030 - October 7, 2025
Stralingsbescherming Level 5B
January 11, 2030 - October 7, 2025
CE Certification of Medical Device
January 11, 2030 - October 7, 2025
Prince2 Foundation & Practitioner
January 11, 2030 - October 7, 2025
Introduction to Quality Management for Medical Devices and ISO 13485
January 11, 2030 - October 7, 2025
Introduction to Design Control for Medical Devices Software
January 11, 2030 - October 7, 2025

Industry Experience

Healthcare, Life Sciences, Manufacturing, Professional Services, Other

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