Keywords
Skills
Other technical skills:
CT dataset, C, JAVA. MATLAB, SIMULINK toolkit, Javascript, HTML, CAD software, NX CAD, Geomagic, Paraview, ADAMS, DICOM, PACS, Amira, OsiriX, LhpBuilder®, NMS Builder, Bonemat©, PC, MAC. Microsoft Office, LaTeX, SAP, CAQ, 3D printing.
Medical Device Regulation: ISO13485, ISO14971, MDR, FDA 21 CFR 820.30, Notify Body Audits
Project history
Direct overall activities relating to planning, designing, and product development of ceramic implants. Oversee processes involved in manufacturing and testing of internal design by gathering requirement, coordinating operational tasks, and streamlining goals into clear and achievable targets. Lead a high performance team, encompassing product managers, R&D, production managers, and quality/regulatory affairs managers. Define control measures to optimise risk evaluation process and effectiveness of on-going monitoring. Introduce Agile within the organisation, serve as agile coach, and deliver excellent training to project managers. Steer several facets surrounding risk management and analysis, while ensuring utmost compliance with ISO14971. Gather data relating to on-going projects and create a presentation, involving status timeline, budget, risks, and opportunities.
Key Contributions:
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Attained research fund by writing grant for EU-funding and led Ceramic 3D printing research projects.
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Headed research and development projects to create/characterise new ceramic porous surfaces/structures for better bone integration.
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Planned and presented in Project Management conference innovative method to improve performance.
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Devised, developed, deployed, set-up, and maintained IT tools for planning and monitoring of project budgets/timeline and reduce planning time.
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Administered a project portfolio of up to three projects at a time with budget worth €2M, time constraint of one to three years, and team of ten members.
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Secured approval without any deviation during TUEV ISO 13485 Audits by developing and documenting processes in line with ISO 13485 and FDA 21 CFR 820.30.
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Planned, developed, and introduced initiatives by creating and implementing key approaches based on Scrum/XP/ Kanban and in line with best practices of Agile project management.
budgetary and time constraints, whilst meeting and exceeding contracted requirements; reported directly to EU
commission. Steered a project team of 20 international members both locally and remotely across EU, US, and UK.
Led processes involved in creation and presentation of exceptional reviews to EU reviewers.
Key Contributions:
* Aided in preparation two projects and secured grant from EC and UK national funds of €10M.
* Reported and presented project for review to EC reviewers and attained Budget financing without any major
deviation.
* Managed a project portfolio of three EU-projects worth €15M ensuring timely handover in line with set
expectations.
* Leveraged patients' data, including X-Ray - CT scans and motion analysis to develop software for clinical
decision support applications based on personalised muscle-skeletal modelling.
requirements; reported directly to EU commission. Steered processes involved in review preparation and
presentation to EU reviewers. Led international project team of 20 partners distributed across EU, US.
Key Contributions:
* Set-up of innovative project management method ant tools based on XP (eXtreme Programming agile
approach) to facilitate collaboration of the distributed team.
* Headed software development of clinical decision support applications based on personalised muscle-skeletal
modelling created from X-Ray - CT patients' data.
models, gait analysis). Led activities relating to definition of requirements and for end-user testing. Aided surgeons
in hip surgical planning starting from CT datasets.
Key Contributions:
* Conducted research study to analyse morphological and densitometry tibial bone remodelling in paediatric
oncological patients based on CT images and CAD presented in Congresses and published as paper in 2009.