• Lead, coordinate, and manage complex software projects involving cross-functional and multidisciplinary teams while managing dependencies across many concurrent projects• Manage the progress and milestones of the full software development life cycle using Aha! and Jira including coordination of requirement definition, user interface design, software development, QA, software release, maintenance, and regulatory requirements• Manage data strategy with AI/ML and product teams to execute AI validation and clinical multi-reader multi-case studies for FDA 510k submissions • Coordinate research collaborations with R&D and Legal teams for external clinicians and KOLs • Coordinate language translation submissions with engineering and external translation company

• Led and facilitated QA efforts in AI automated workflows for cardiac MR and CT, interventional planning, and cloud-based reporting• Managed multiple QA and engineering teams while collaborating with product, design and other stakeholders within an aggressive agile environment to ensure quality product releases• Contributed as a subject matter expert on clinical workflows in next gen products• Wrote and reviewed technical files for product releases, regulatory submissions, and OEM deployment• Coordinated with DevOps teams to integrate testing activities into the CI/CD pipelines• Implemented strategies for load and performance testing frameworks for scalable product solutions • Performed risk and root cause analysis to identify and address underlying quality issue

• Conducted functional, regression, performance, and user acceptance testing to identify and report defects, ensuring timely bug triage and resolution using Jira Work Management• Coordinated QA efforts for revamping and extending content test coverage for technical calculations• Collaborated with Development and Support teams to complete a cybersecurity assessment for a 510k submission• Worked with Support and Product Management to address and triage Tier 2 customer issues

• Maintained and improved QMS, assuring compliance with 21 CFR Part 820, ISO 13485:2016, ISO 14971:2012, European Medical Device Directives, Canadian Medical Device Regulations and other applicable standards and regulations• Performed detailed gap analysis in preparation for adopting the Medical Device Single Audit Program (MDSAP) and upgrading compliance with the European MDR • Facilitated, trained, and led internal audits• Managed CAPA processes and quality records• Provided QMS training for onboarding and quality updates• Participated in interdisciplinary product development team for conducting risk analysis and reviewing technical documentation

• Experienced in pre-FEED, FEED and Detailed Design stages of pipeline projects• Utilized various industry codes and standards: CSA Z662, CSA Z245, ASME B31, API• Prepared and reviewed technical reports and engineering calculations for project deliverables• Coordinated with procurement and operations teams to provide technical support for RFPs, RFQs, technical bid evaluations, and vendor reviews• Developed and reviewed engineering drawings for technical accuracy and standards compliance (drawing packages include: alignment sheets, crossing drawings, mechanical and isometric drawings)• Notable projects include: Boundary Lake North (TransCanada), Wyndwood Expansion (Spectra), Norlite Diluent Pipeline (Enbridge), Pacific Trails Pipeline (Chevron)

• Delivered innovative engineering solutions while coordinating with a multi-disciplinary team• Designed and prototyped biomedical devices such as surgical equipment for knee and hip arthroplasty, wheelchair with built-in commode and lifting system, power-assisted mobility aid• Designed industrial equipment such as downhole tools, oil tank cleaner, solid oxide fuel cell module• Reviewed design specifications, drawings, and project documentation for technical accuracy• Developed a Risk Management Plan in accordance to ISO 13485 / 14971 for the company QMS • Developed DBM, scoping documents, and other project management documents for project bidding, project monitoring, progress reporting and client / vendor liaison • Conducted project planning / scheduling, man-hour and project cost estimates using LiquidPlanner® • Mentored junior engineers and conducted Lunch & Learn seminars

• Validated a magnetic resonance imaging (MRI) protocol for assessing three-dimensional in vivo tibiofemoral kinematics for the natural knee joint • Planned and conducted an experiment to acquire 2D and 3D fluoroscopy images of a cadaveric knee using the Siemens Arcadis Orbic C-Arm for the purpose of 2D to 3D image registration

• Worked at the world leader in medical technology for cardiac surgery; Mitroflow Division manufactures the Mitroflow Aortic Pericardial Heart Valve• Evaluated the design of a prosthetic heart valve tester; created designs to improve device hydrodynamic performance and operator ergonomics• Specified and optimized a LabView DAQ for acquiring and analyzing hydrodynamic data from in vitro heart valve testing under physiological conditions using ISO 5840

• Designed a charge contact mechanism for cordless telephones (US Patent #7456607)• Created a mathematical model to predict intermittence in a telephone charging circuit• Programmed a visual basic application to calculate assembly time of a cordless phone unit

• Designed and prototyped a handheld luggage weighing device using a 68HC908 microcontroller • Programmed a Siemens 224 PLC to automate a barbless fishhook manufacturing machine and integrated components such as sensors, pneumatic rotary actuators and guided cylinders