Karen Aguiñiga Melendez
Manufacturing / Mechanical
About Karen Aguiñiga Melendez:
Engineering professional with 7 years of experience in medical device product development, specializing in New Product Introduction (NPI), process validation, and project execution under FDA and ISO 13485 regulatory frameworks. Proven ability to lead cross-functional teams through project lifecycle stages — from concept to market ensuring quality, cost, and timeline targets are met. Additional experience in EHS/safety, logistics and customer service.
Experience
Engineering professional with 7 years of experience in medical device product development, specializing in New Product Introduction (NPI), process validation, and project execution under FDA and ISO 13485 regulatory frameworks. Proven ability to lead cross-functional teams through project lifecycle stages — from concept to market —ensuring quality, cost, and timeline targets are met. Additional experience in EHS/safety, Logistics and customer service.
Education
Bachelors degree as Industrial
engineer
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