Manufacturing Engineer II

Intuitive Surgical, S. de R.L de C.V.; Mexicali; Presencial; MXN 300.000 - 420.000; Jornada completa

Descripción de la vacante

Intuitive Surgical, S. de R.L de C.V. in Mexicali seeks a Manufacturing Engineer to drive sustaining activities and continuous improvement in medical device manufacturing.

You will lead ECO implementations, RCA initiatives, and PFMEA-based risk assessments, while updating IQ/OQ/PQ validation protocols and supporting data-driven decisions across functions.

Formación

• Bachelor of Engineering in Industrial Engineering, Mechanical Engineering, Mechatronics, Electrical, Electronic or equivalent.
• 3+ years as Manufacturing engineer in a medical device company preferred.
• Must speak/read/write in English.
• Strong RCA experience and lean manufacturing tools (yellow belt preferred).
• Strong communication across teams and cultures.
• PFMEA awareness and IQ/OQ/PQ validation protocols background.
• Experience with SAP transactions and Agile.
• Review and/or approve ECOs (Engineering Change Orders).

Responsabilidades

• Sustaining Activities & Continuous Improvement with RCA using Lean tools to reduce manufacturing failures and improve process performance.
• Coordinate ECOs implementation to support process optimization and controlled manufacturing changes.
• Coordinate operator training to support successful implementation of process changes.
• Analyze Yield, Failure Rate, and Scrap metrics to identify improvement opportunities and data-driven decisions.
• Lead Engineering Changes & Project Implementation coordinating new materials, EFTs, fixtures and process enhancements into MPIs, BOMs, and Travelers.
• Update IQ/OQ/PQ validation protocols to support manufacturing process changes.
• Lead cross-functional projects and Management of Change (MOC) activities.
• Lead scrap and failure rate reduction projects across initiatives.
• Quality & Compliance investigations and NCR/VR resolution support.
• Perform traceability reviews and risk assessments using PFMEA documentation.
• Ensure compliance with Work Instructions, SOPs, DOPs, and Quality System requirements.

Conocimientos

Root cause analysis

Lean manufacturing

SAP

Agile

PFMEA

Communication

IQ/OQ/PQ validation

English proficiency

ECOs

Educación

Bachelor of Engineering in Industrial/Mechanical/Mechatronics/Electrical/Electronic or equivalent

Herramientas

SAP

Descripción del empleo

• Sustaining Activities & Continuous Improvement Performing RCA using Lean Manufacturing tools to reduce manufacturing failures and improve process performance.
• Coordinate ECOs implementation to support process optimization and controlled manufacturing changes.
• Coordinate operator training activities supporting successful implementation of manufacturing process changes.
• Analyze Yield, Failure Rate, and Scrap metrics to identify improvement opportunities and support data-driven decision making.
• Engineering Changes & Project Implementation Lead and coordinate manufacturing process improvements through the implementation of new materials, EFTs, fixtures, and process enhancements, ensuring successful integration into MPIs, BOMs, and Travelers.
• Update IQ/OQ/PQ validation protocols to support manufacturing process changes.
• Lead cross-functional projects and Management of Change (MOC) activities.
• Lead scrap and failure rate reduction projects, achieving reductions in several initiatives.
• Quality & Compliance Investigations and support resolution of NCRs and VRs.
• Perform traceability reviews and risk assessments using PFMEA documentation.
• Ensure compliance with WIs, SOPs, DOPs, and Quality System requirements.

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%.
• Strong RCA experience
• Lean manufacturing tools(yellow belt is a preferred)
• Strong communications skills across team organizations and cultures.
• Strong IQ/QO/PQ Validation protocols background
• PFMEA
• Experience with SAP transactions and Agile.
• Review and/or approve ECO (Engineering Change Orders)

Required Education and Training

• Bachelor of Engineering in Industrial Engineering, Mechanical Engineering, Mechatronics Engineering, Electrical Engineering, Electronic Engineering or equivalent.

*the start date for this position is in January 2027 Q1