Canada
Results-driven PEng with 5 years experience in research and development, leading projects from concept to commercialization for in-house and client needs. Expertise in implementing cutting-edge technologies, adhering to regulatory standards (ISO 13485), and providing project-level leadership. Proficient in 2D/3D modelling software, risk management (ISO 14971), and biocompatibility (ISO 10993), with substantial hands-on experience with various manufacturing processes. A dynamic and flexible self-starter known for superior communication skills and a passion for biomedical technology. Don't hesitate to get in touch with me to find out how I might contribute and add value to your organization.
As a Process Validation and Test Engineer at Traferox Technologies, I lead the development and execution of validation protocols for equipment qualification, including URS/PRS, FAT, DQ, IQ, OQ, and PQ, in compliance with cGMP and regulatory standards. I assess the impact of design and process changes on product performance and regulatory compliance, supporting cross-functional teams in documenting changes and ensuring timely completion of validation activities. My work involves gap analysis, corrective actions, and driving process improvements through data-driven insights. • Developed and executed validation protocols for equipment qualification and product changes, ensuring adherence to regulatory standards (FDA, ISO 13485, EU MDR). • Led the verification and validation (V&V) of design changes and product updates, ensuring compliance with cGMP and industry regulations. • Collaborated with R&D, quality, and regulatory teams to document and validate product specification changes. • Conducted root cause analysis and CAPAs for product quality issues identified during V&V activities.
As a Manufacturing and Field Service Engineer, I collaborate extensively with cross-functional teams, including R&D, Quality Assurance, and Production, to ensure seamless manufacturing operations. My responsibilities encompass designing and optimizing manufacturing processes, workflows, and assembly methods to enhance efficiency, reduce costs, and elevate product quality. I also contribute to the New Product Introduction (NPI) process by providing engineering expertise in evaluating new designs and supporting validation activities. Additionally, I serve as a technical resource for clients, delivering on-site servicing and maintenance of medical equipment while ensuring adherence to manufacturer specifications. My proactive approach to continuous improvement involves identifying opportunities for process enhancement and actively participating in root cause analysis. Meticulous documentation of all activities ensures compliance with regulatory requirements and supports future submissions.
In my role, I work on R&D for new products in Anesthesia, Hemodialysis, Cardiovascular, and Oncology. I collaborate with internal and external partners to identify product development opportunities, reorganize documentation to address gaps and participate in supplier qualification/ risk analysis and biocompatibility tasks. Additionally, I oversee validation tests, contribute to the production and quality assurance documentation, support pre/post-marketing activities, and ensure compliance with quality assurance requirements through equipment maintenance and staff training during design changes or new device introductions.
Graduate Teaching Assistant for the School of Engineering ENGG* 3700- Optimization for Engineers (1 term- Fall) Student Consultation during Tutorials/Office hours Email Correspondence/Monitoring Invigilating Exams Grading both Midterms/Exams
Thesis Title: Testing Commercially Available Thin-Film Force Sensors for the Implication in Carpal Tunnel Sensitive Devices Principal researcher on wearable medical device development and statistical analyst Managed project’s; cost, inventory procurement, risk management and Standard Operating Procedures(SOP) and clinical documentation throughout the full project’s scope. Develop analytical modelling, simulations and experimentation reports for presentation applications and review purposes. Data manipulation/modelling in Matlab, SPSS, Minitab, Excel. Created Ethical reports/documentation under governing board regulations. Conducted (pre/post-trial) subject interviews, Performed patients screening, preparation, testing procedures and test scheduling.
Graduate Teaching Assistant for the School of Engineering ENGG*2450- Electric Circuits (2 terms- Winter/Spring) Student Consultation during Tutorials/Office hours Email Correspondence/Monitoring Conducting Labs Invigilating Exams Grading both Quizzes/Midterms/Exams