Led the transfer of manufacturing line equipment from Facility A to Facility B, ensuring minimal downtime and seamless integration. Coordinated with cross-functional teams to develop and implement transfer plans, including timelines, resource allocation, and risk assessments. Conducted equipment validation and qualification processes, ensuring compliance with industry standards and regulatory requirements. Support production downtime during PPQ validations. Supervise staff on new equipment and processes, ensuring adherence to safety and operational procedures. Documented all transfer and validation activities, maintaining comprehensive records for audit and compliance purposes. Create, change or update engineering documentation through Agile. Follow up on defect trends applying root cause analysis to implement corrective actions Acquire tools or fixtures through Coupa to improve and streamline the manufacturing process. Required Skills and Experience 3 years at least as Manufacturing engineer in a medical device company (preferred) Must be able to speak, read and write in English 85%. Electric test knowledge of the process Must be able to travel to the USA. Strong communications skills across team organizations and cultures. Strong PPQ Validation background PFMEA Required Education and Training Bachelor of Engineering in Mechanical Engineering, Mechatronics Engineering, Electrical Engineering, Electronic Engineering or equivalent. Preferred Skills and Experience Equipment repair Mexico – US Customs and supply chain knowledge. Mid/high volume complex mechanism manufacturing engineering experience. Experienced in ISO 13485, or medical device manufacturing environment. #J-18808-Ljbffr
Manufacturing Engineer Ii
INTUITIVE SURGICAL, S. DE R.L DE C.V.
mexicali, mexicali
Publicado hace 26 días
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