Soundharya Mahadevan

Product Development Engineer @AliMed

Dedham, MA, US

Experienced medical device engineer with a strong background in product development within FDA-regulated and EU MDR-compliant environments. Skilled in designing and launching devices from concept through commercialization, with a focus on DFM, risk mitigation, and regulatory compliance. Created and managed detailed technical documentation including specifications, IFUs, SOPs, and Technical Files, and have played a key role in transitioning products from Class I to Class II. My work includes root cause analysis, CAPA implementation, and test protocol development. Trained engineers, led cross-functional initiatives, integrated new capital equipment into development workflows, and collaborated globally to drive product improvements.

North Attleboro High School

High School Diploma

The College of New Jersey

Bachelor of Science - BS, Biomedical/Medical Engineering