Biomedical engineer with over 15 years of experience in the medical device and pharmaceutical industry. Highly skilled and results-driven engineering professional with a solid track record in research and development (R&D), manufacturing engineering, and product development within the medical device and pharmaceutical industry. Demonstrated expertise in designing and developing innovative solutions for combination product development, heart valve therapy, critical care electronics, and blood diagnostic systems. Adept at managing projects from concept to completion, ensuring quality, efficiency, and adherence to industry standards. Proven ability to lead cross-functional teams and successfully implement process improvements. Complemented by an MBA with a focus on innovation and entrepreneurship, enhancing strategic business acumen.

Skills: Process qualification (PPQ), Process requirements documentation, automated process documentation, process efficiency improvement, root cause analysis, fixture development, IQ/OQ/PQ, software validation, process validation, software testing, hardware testing, software design, design controls, combination product development and qualification.