Toronto, Ontario, Canada
Strategic and technical leader. Proven track record of defining and delivering on objectives in a dynamic environment. Multi-disciplinary engineer with 17+ years product development experience in the medical device space (Class II IVD, Class II Cardiovascular, Class III Active Implantable Neuromodulation, Class III Perfusion). Established ability to build, develop and manage cross-functional teams. Extensive experience working within QMS frameworks and product development lifecycles. Areas of expertise: - Defining product development programs and overseeing execution across multiple streams - Application of medical device standards (IEC60601, IEC61000/FCC/CISPR11, EN45502, ISO13485, ISO14971) - Technical leadership to ensure compliance to regulations (Health Canada, FDA, PMDA, NMPA, EUMDR) and supporting MDSAP audits
Traferox Technologies was built around the goal of developing innovative products to improve transplantation. Our mission is revolutionizing organ transplantation, grounded in world-class science.
Conavi Medical is a medical device company focused on providing image guidance technologies for minimally invasive cardiovascular procedures. • Key member of senior management team defining company objectives, resource plans, budgets and timelines • Defined product development strategies and next generation roadmaps • Oversaw product development across systems, catheter, software and firmware, including CDMOs • Drove systems integration function across teams and departments
• Managed full product development for Novasight IVUS OCT and Foresight ICE products - risk, integration, V&V • Established expanded R&D team covering mechanical, electrical, optical and control systems functions • Managed product compliance and regulatory strategies for expansion to markets outside of North America (Japan, China) • Established service and field support programs
• Full-cycle development for Novasight IVUS OCT product, a novel ultrasound and optical imaging platform • Lead for hardware design, electronics, systems integration and product compliance (safety, EMC) • Managed key product development milestones, including first-in-man, 510(k) clearance, NPI to manufacturing
Additional Responsibilities: • Integral contributor across instrument, consumable and assay design and development, from a systems integration and DFM perspective • Technical lead on system integration activities, as well as internal and external studies at partner sites • Managed small team of engineers and technicians through beta and pre-clinical product development • Extensive electronics design and cost optimization for the X1 system • Led pre-clinical instrument verification and design, and additional activities with regulatory impact • Defined project plans, managed progress and scope within overall development timeline • Liaison between development groups to generate specifications and design instrumentation, fixtures and software
Private company developing a rapid point-of-care diagnostics system, aiming to decentralize laboratory testing without compromising diagnostic sensitivity. Technology is based on a novel molecular detection platform with multiple commercialization routes. Class II IVD Device. Specific Responsibilities: • Analog and digital electronics design for both the product and internal instruments, including test and verification fixtures • Circuit simulation and testing activities (full verification and validation per QMS / medical device standards) • All aspects of CCA realization (schematic capture, complex PCB layouts, part sourcing, procurement, BOM generation, as well as outsourcing and managing builds) • Optimization and re-design of existing instruments and circuit designs • Drive full software development (from definition of input specifications to final implementation), including firmware and algorithm development, GUI workflow and state machine definitions, as well as management of third-party software contractors • Quality Management System activities (authoring SOPs, training, FMEA and risk assessment methods, DHF/DMR, sign-off on verification and validation activities) • Manage external vendors and communication with other third-party partners • Microfluidics troubleshooting, optimization and script definition • Design of mechanical parts and drawings in Solidworks • Development within medical device standards (13485, 62304, 14971, FDA 21CFR820)
Founding member of this start-up company developing Bedside Transvascular Dual Phrenic Nerve Stimulator for Assisting Mechanically-Ventilated ICU Patients. • Design, implementation, review and PCB design of low-level circuitry according to Class III Active Medical Device standards (IEC60601, EN45502) as part of Embedded Electronics Team. • Testing, troubleshooting and debugging of hardware, software and firmware in preparation for pre-clinical experiments; verification for standard compliance (i.e. defibrillation and leakage testing). • Creation and review of specification documents (requirements) for various stages of state machine/firmware/system development, from design input stage forward. • Identification of and communication with vendors/suppliers for both custom and off-the-shelf component procurement. • Experience with QMS environments, including writing SOPs, test protocols/reports, training, document control, design history, risk analysis/FMEA. • Entry-level management (intern), consisting of milestone identification, timelines, technical guidance, reporting and progress updates. • Development of version-control system for hardware design and document control. • Filing a provisional patent. • Coordination, planning and supervision of short- and long-term pre-clinical experiments. • Designing and programming experimental software for data acquisition and analysis for pre-clinical experiments. • Creation of real-time automated algorithms for experimental data analysis.
Resident electronics engineer in a research lab setting. Work also resulted in Honours thesis for B.A.Sc, various publications and led to a spin-off company (Lungpacer Medical) where I became the first employee. • Creation of 3D mathematical and graphical models to approximate transvascular stimulation of a nerve for various designs and orientations, including FEA. • Development of a complete stimulation and data acquisition system (both hardware and software), including interfacing custom electronics with off-the-shelf products to meet requirements. • Managing data collection and automated analysis of physiological data, at times required to oversee a small team. • Documentation, data publication and research paper submissions.