Dedicated & Experienced
TUV-SUD UK Ltd
Medical Device Auditor
Auditing Quality Management Systems ISO13485, Risk Management ISO14971, IEC60601-1 Safety and Essential Performance, ISO17025 Calibrated Laboratories, ISO17065 Certification Bodies, IEC62304 Software Lifecycle Process, MDSAP, MDD / MDR, Regulatory and Global Market Access for active medical products.
July 2013 - September 2020
UL International (UK) Ltd
Managing a medical and laboratory equipment safety engineers team located in UK, Guildford. Business growth and development (200% growth in 5 years), tools and processes improvement (NPS +40% growth in 2 years). Medical products evaluation, testing and certification. Project handler and project reviewer. Training customers and engineers in medical safety, risk management, usability, software lifecycle process, alarm systems.
Lead of a medical and laboratory equipment safety team located in UK, Guildford. Managing a team of 6 – 7 direct reports. Supervision of a safety testing laboratory, calibration management, CBTL scope management.
February 2008 - July 2013
UL International Polska
Safety evaluation of medical products, over 200 products evaluations. Safety certification for all major markets: EU, USA, Canada, Brazil, India. Performing test programs at CB Scheme laboratories and clients’ facilities (UK, Germany, China, India), test reports writing, assessments of technical documentation (safety reports, RM, Software, Usability, Alarms). Project Reviewer, over 500 safety reports reviewed. Linear Accelerators, Radiotherapy, Medical Robots, Ventilators, Defibrillators, Monitoring, Home Healthcare, Alarm Systems.
March 2007 - December 2007
Specialist - Medical Architectural Systems
Design (AutoCAD LT 2007) and delivery of medical supply systems (Agila, Movita, Ponta, Gemina), operation lamps (Stella, Sola) dedicated for Intensive Care Units, Emergency Care Units and Operation Rooms. Creating and pro-active offering (B2B presentations) of complex solutions for Operation Theatres, ICUs and ECUs. Coordination and evaluation of work progress with design offices and investors at hospitals (field inspections and projects coordination in the field). Marketing meetings and presentations for key clients. Maintaining B2B contacts.
May 2005 - December 2006
Installation and maintenance of automatic injectors for contrast media, models Vistron, ProVis, MCT+, Solaris. Integration with hospital Computed Tomography and Magnetic Resonance Systems. Delivery of training for medical personnel. Provided over 50 independent installations and trainings, over 100 repairs and service maintenance procedures conducted on medical devices in hospitals around whole Poland.
January 2005 - May 2005
Repair of laboratory equipment dedicated for building materials testing. English to Polish translation of technical manuals and products documentation. Meeting key clients.
June 2003 - June 2005
Institute of Nuclear Energy
Engineer - Dosimetry
Design and testing of dosimetry apparatus dedicated to radiation safety measurements in medicine (medical linear accelerators).
September 1999 - January 2007
Warsaw University of Technology
MSc. Eng. in Biomedical Engineering & Biocybernetics
Field of Automatics and Robotics
Biomedical Engineering full time studies