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Medical Device Field Service

Location:
Richmond Hill, Ontario, Canada
Posted:
May 06, 2019

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Resume:

Professional Profile

A dynamic, accomplished, multilingual Research Scientist and Educator highly regarded for expertise in Clinical Trials, Biomedical Engineering, Biomechanics, imaging technology, and Medical Device Development in support of healthcare, medical device technologies and educations.

10 years’ post-secondary teaching experience and 7 years’ experience in Medical Instruments and Devices, Biomechanics, software development, algorithm development and product development.

Sought for strong ability to cross-function as a team member, leader, problem solver and relationship building with working knowledge of cGMP, ICH GCP, FDA, ISO 13485 and OSHA regulatory guidelines.

Excellent communicator with in depth knowledge of coding in C++, MATLAB, experimental design, quality assurance, biophysics, cell and viral culture, animal and human study.

Work Experience

Research Scientist ò York University òToronto, 2017 – Present

Portable Thermo-Photonic Device such as using a cellphone attachment infrared camera for Roadside Detection of Cannabis Consumption for detecting delta-9-tetrahydrocannabinol.

.Leading all phases of the cutting-edge medical device development and clinical studies including concept, design, prototyping, modeling, validation testing, regulatory documentation, manufacturing transfer, and post-market evaluations.

Manage study design, resource requirements, budgeting, study execution, data analytics, and development of scientific papers.

Lock-in thermography using a cellphone attachment infrared camera to pave the way for development of low-cost thermography systems and their commercialization as inexpensive tools for non-destructive testing of industrial samples as well as affordable clinical devices for diagnostic imaging of biological tissues.

Using FTIR Spectroscopy for quantitative analysis of biological samples to determine the index of absorption, index refraction, and their physical characterizations.

Clinical Research Scientist ò St. Michael's Hospital òToronto, 2016 – 2017

Leading project execution for process optimization and technology development programs in medical device technology development including task definition, experiment design and execution, data analysis and documentation, reporting, and recommendation.

Worked closely with software developers and mechanical engineers in the development of new biomedical processes and products.

Provided clinical application support, reviewed the medical technology profile, identified problem areas and risk exposure, and provided solutions for short and long-term improvement of biomedical, clinical engineering, and technology support.

Working knowledge of regulatory guidelines to prepare reports for submitted products as well as required documentation for the regulatory authorities such as preparation of SOPs, BPRs, and validation reports.

Conducted clinical research involving animal study and cell culturing to diagnose carotid artery disease and breast cancer.

Helmed critical projects using the MEMS-VCSE OCT Optical and orchestrated flawless development of Optical Coherence Tomography technique for clinical diagnostics and treatment using Gold Nano Particles (GNP), diligently managing timelines, team assignments, resources, and cost.

Identified, evaluated and recommended new and existing technologies to improve cell therapy workflows.

Worked from the theoretical level to the clinical level with strong interaction with software engineering groups, the mathematical modeling and physical implementation of biomedical solutions, and clinical testing of new development.

Research Scientist ò St. Michael's Hospital ò 2015 – 2016

Maintained strong professional relationships with Key Opinion Leaders (KOLs) and clinical research sites in partnership with Institute for Biomedical Engineering, Science and Technology, and St. Michael’s Hospital.

Designed, issued, and evaluated clinical trials to develop and modify cell therapy to scale-up for technology transfer and obtain a stable and bio-equivalent product.

Proven skills in clinical application driving the best possible results in a fast-paced environment, integrating best practices to streamline workflows, and improving overall productivity.

Assisted with failure investigations to identify the cause of failure, designed investigation protocols, prepared deviation reports, and Corrective Preventative Actions (CAPA) documentation.

Participated in training sessions for the proposal, investigation, and introduction of new technologies and services for St. Michael's Hospital, assisted in the failure investigations within other groups, designed investigation protocols, and suggested corrective actions.

Provided high quality, cost-effective biomedical and clinical engineering, and technology management services to St. Michael's Hospital customers.

Research Associate ò Biomedical Physics Department ò Ryerson University ò 2008 – 2016

Maintained technical expertise through knowledge of clinical literature, attendance at professional conferences and participation in team meetings.

Excelled on a retina and optic nerve as a model to study neurodegenerative diseases such as Alzheimer disease by using OCT.

Demonstrated, for the first time, an SW-OCE technique that uses ARF for the mechanical excitation of a carotid sample to measure the shear modulus and Young’s modulus of the adventitia.

Applied biochemical engineering principles including mass and heat transfer, fluid dynamics, process control, process simulation and modelling, and equipment design.

Developed Optical Coherence Elastography (OCE) for the diagnosis of cancer and coronary artery disease

Applied ARF-OCT to detect the microscopic enhancement of nanoparticle/gold nanoparticle into a collagen matrix and MCF-7 breast cancer cell. Used different collagen concentrations for a tissue engineered MCF-7 breast cancer cell construct.

Biomedical Sales and Support ò Sima Medical Device Company ò 2000 – 2008

Provided high quality, cost-effective biomedical and clinical engineering, technology management, and technical services to healthcare and medical device industries.

Primary interface between customers, field service, sales and marketing associates, and leadership associates for the assigned products.

Collaborated with Technical Support and Field Service to help resolve escalated complex product issues.

Education

PhD, Biomedical Physics, Ryerson University

Dissertation: Development of Optical Coherence Tomography (OCT) Technique for Clinical Diagnostics and Monitoring

MSc, Biomedical Physics, Ryerson University

Thesis: Optical Coherence Elastography (OCE) Imaging of Shear Wave Propagation in Ex-Vivo Tissue

Affiliated Associations

Ontario Society of Professional Engineers

Optical Society of America

International Society for Optics and Photonics

Optical Group Research, Gordon Research Conference



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