Anesh Tilwani

As a Staff Quality Engineer at iota Biosciences, Inc. powered by Astellas, I apply my 10+ years of experience and passion for the field of quality, manufacturing, and research to the development of innovative Class III medical devices. I am a certified Quality Engineer (CQE) and Six Sigma Green Belt (CSSGB) with a master's degree in biomedical engineering.

I have extensive knowledge and experience with CAPA, FMEA, design control, V&V, process validation, and various quality standards and regulations, such as 21 CFR 820, ISO 13485, ISO 14971, CLIA, MDR, and IVDR. I also have a strong background in process improvement and design methodologies, such as Six Sigma, Lean, DFSS, and TQM, and statistical and DOE tools and concepts, such as ANOVA, hypothesis testing, factorial design, and cause-and-effect. I have contributed to the end-to-end product development life cycle of multiple FDA-approved products, such as ultrasound devices, X-rays, ECGs, bedside monitoring devices, DNA sequencers, and diagnostic screening tests for various types of cancer and genetic disorders.

Additionally, I have a unique expertise in biocompatible and photostable luminescent nanoparticles, which I have used for effective biomedical imaging and received multiple awards and publications for.

I am a result-oriented, hard-working, creative, dynamic, flexible, and collaborative quality leader who strives to come up with out-of-the-box ideas and solutions for the healthcare world. I am always eager to learn, grow, and take advantage of every opportunity that comes my way. My mission is to deliver high-quality, safe, and reliable medical devices that improve the lives of patients and healthcare providers.

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