Karthik Natesan

I am an Engineering Project Manager with 18+ years of experience leading complex electromechanical systems in both aerospace and medical device industries. I specialize in guiding cross-functional teams—including mechanical, electrical, and firmware engineers—to translate early-stage concepts into reliable, manufacturable designs. My expertise spans full product lifecycle management, regulatory compliance (ISO 13485, FDA 21 CFR Part 820), risk management (FMEA), and iterative/Agile development processes.

I have successfully delivered projects for top medical device clients such as Roche, Bayer, Medtronic, and Alcon, as well as aerospace programs requiring high precision and stringent quality standards. I thrive in collaborative, innovative teams and am passionate about developing solutions that improve people’s lives and advance technology.

Over 18 years of progressive experience leading complex electromechanical and medical device projects across aerospace and healthcare industries. Demonstrated expertise in full product lifecycle management, guiding multidisciplinary teams (mechanical, electrical, firmware) from concept through prototyping, testing, and manufacturing. Skilled in regulatory compliance (ISO 13485, FDA 21 CFR Part 820), risk management (FMEA, hazard analysis), and iterative/Agile development processes.

Successfully delivered projects for leading medical device clients including Roche, Bayer, Medtronic, and Alcon, as well as high-precision aerospace programs. Proven ability to drive innovation, optimize processes, and deliver high-quality solutions in regulated and technical environments.

Bachelor of Engineering (Mechanical Engineering). Certified Project Manager – Wipro PMI Academy. Certified SolidWorks Professional (CSWP). Strong foundation in mechanical and electromechanical design, product development, and project management, complemented by professional certifications in CAD and engineering leadership.