Hifza Najib

About Hifza Najib

I’m a cross-functional leader and scientist with deep expertise in wearable sensor systems, diagnostics, and health technology. Over the years, I’ve contributed to the development and launch of innovative medical products — including initiatives that supported national health efforts during COVID-19.As a Senior Scientist and Innovation Lead, I’ve helped secure patents, build early-stage product concepts, and guide them toward technical feasibility and strategic funding. I’ve driven high-visibility projects by aligning cross-functional teams across R&D, clinical, regulatory, and business functions, and my work has been recognized through internal innovation awards, conference presentations, and organization-wide visibility.I thrive in roles that require both technical depth and strategic vision — especially where chemistry, biosensing, and systems integration converge. While I’m naturally innovation-driven, I also bring a pragmatic understanding of the regulatory landscape, having contributed to product submissions, approval strategies, and warning letter remediation efforts. This blend of creativity and compliance enables me to help move bold ideas through real-world constraints — and ultimately into the hands of patients.I\'m especially passionate about translating complex science into meaningful health impact, particularly in underserved spaces like personalized health and chronic disease.

Experience

1. Sr Scientist - Process Development Engineering

   Dexcom

   Aug 2024 — Present

   Led cross-functional remediation efforts following an FDA warning letter by defining new product requirements and aligning Quality, Regulatory, Systems Engineering, Clinical, and Manufacturing teams. Supported internal and FDA audits, contributing to documentation and resolution strategies. Drove commercial manufacturing improvements, increasing yield by 10% and delivering $10M in annual savings. Analyzed large-scale manufacturing and clinical data to identify root causes of accuracy issues; recommended design, testing, and process changes to improve device performance and field reliability.

Education

• University of Toronto School of Continuing Studies

  Project Management

• University of Toronto

  Masters of Science

• UC San Diego Extended Studies

  Regulatory and Statistics Courses

• University of Toronto

  Bachelors of Science