Mississauga, Ontario, Canada
I am a R&D leader in medical device engineering. I have been working in the medical device industry for 20 years, with the last 6 years as the head of R&D. I have a core knowledge of design and manufacturing, specialized in medical technology, and a broad skill base encompassing software development, electrical engineering, information technology, regulatory compliance, and project management. In all my past and current positions, I have steadily expanded my responsibilities, welcomed new challenges, and maintained a focus on delivering results and on solving business problems.
Traferox creates, manufactures and commercializes products that employ technologies invented by the surgeon team of the University Health Network (UHN) to improve surgical outcomes and save patients’ lives.
Profound Medical is commercializing a minimally invasive, MRI-guided ultrasound therapeutic device to ablate prostate tissue, intended to treat prostate cancer. Main Duties: + Build and manage a team of up to 20 mechanical, electrical, software and systems engineers, including managers and oversees employees + Plan, launch and oversee R&D projects and directly manage projects as needed + Continuously improve the company products and ensure regulatory compliance + Manage research collaborations with world-leading academic researchers + Apply for government funding for R&D projects + Manage relations with contract manufacturers + Work with IP lawyers to manage and grow the company's patent portfolio + Other duties as needed, including sales and relations with MRI vendors
Profound Medical is working to commercialize a minimally invasive, MRI-guided ultrasound therapeutic device to ablate prostate tissue, intended to treat prostate cancer. Main Duties: + Build and manage a team responsible for the development, test and certification of MRI-related aspects of the medical device + Build and manage a team responsible for the electrical development, test, certification and design transfer of the medical device + Establish a strategy and oversee the execution of plans to support multiple 3rd-party MRI scanners + Support the planning, development and execution of clinical trials + Support regulatory submissions of medical devices + Participate in the development of high level system requirements, project schedules and budgets, human factors engineering, risk management, reliability engineering, and evolution of the quality management system + Participate in recruitment, interviewing, and hiring decisions.
Natus Medical Incorporated is a world-leading manufacturer of medical devices used in Neurology (electroencephalographs, electromyographs, and intra-operative monitors). Main duties: + Manage an international team of around 20 employees across several corporate sites: system engineers, IT specialists, system testers, and technical writers; + Strategically harmonize system engineering and testing activities across all Natus sites to develop a corporate culture; + Manage systems engineering at Natus Neurology: specify, qualify and integrate Natus hardware and software with third-party equipment to be used in medical systems; + Manage, as needed, software development, hardware design and regulatory projects. + Manage sustaining activities and value engineering (functional improvement and cost reduction) for existing products; + Oversee system testing (software quality assurance); + Organize and drive all safety testing (IEC 60601 standards), risk management and usability engineering for medical devices; + Organize and drive compliance to environmental regulations (RoHS, REACH); + Ovesee all efforts to ensure that medical devices meet customers' expectation as they integrate in their IT infrastructure; + Work with operations team and contract manufacturers to quickly resolve all manufacturing problems; + Participate in the hiring and training of managers, engineers, testers, and other employees;
Main duties: + Essentially same as duties for Systems Engineering Functional Manager, but limited to Excel Tech Ltd. + Manage on a full-time basis a team of up to 6 system testers and one hardware engineer, as well as other hardware and mechanical engineers and software developers as required by each project.
Cardiogenics is a small company developing an innovative point-of-care analyzer to perform immunoassays on human blood. Duties: + Develop the software (application and OS) for an embedded system used in an in vitro diagnostics device; + Testing performance of analyzer and chemical reagent systems; + Automating routine laboratory experiments; + Managing external R&D partnerships with suppliers and consultants.
Working on merging Magnetic Resonance Imaging and Bioluminescence Imaging on live small animals. In collaboration with Xenogen (Alameda, California) Research work consisted in: + Combining bioluminescence and magnetic-resonance images of live mice; + Developing algorithms to reconstruct 3D images of bioluminescence; + Designing and testing radiofrequency MR coils. Supervisor: Prof. R. Mark Henkelman