Alejandro Herrera

Background

About Alejandro Herrera

A result driven, product development engineer, with over 30 years of experience. Provide leadership and assist clients by providing “turn key” solutions to their engineering and project management needs. Will provide full Product Design and Development Engineering services, from concept to production, utilizing over 30 years of extensive experience, from turn key product to individual component design and analysis. Whether your product is a high volume medical or consumer product or a high value engineering solution, I will apply proven project methods and engineering tools to satisfy your needs to bring your product to market in a timely manner. This product development process allows me to maximize client satisfaction, concentrating on the following requirements. • Product safety and efficacy • Product safety and reliability • Compliance with associated regulatory or safety standards (FDA,MDD, ISO, IEC, UL, CE, CSA) as required. • Desiign for manufacturing. Following a comprehensive Design Control Process where the deliverables for each phase and the criteria for completion are set; allows to monitor each project to ensure that client expectations for timing, cost, and quality are met. Specialties: Proficient at all phases of the product development engineering design process and project management, excel at bringing product design and development through production. Regulatory experience per FDA CFR title 21 part 820, cGMP requirements ISO-13485, MDD 93/42/EEC (Council directive), IEC 60601-1 medical device quality and safety standards. ISO-14971 Risk management.