Manufacturing Engineer II - Lean & Continuous Improvement

Intuitive; Mexicali; Sur place; MXN 360 000 - 540 000; Plein temps

Résumé du poste

Intuitive is seeking a Manufacturing Engineer to lead Lean implementations and drive continuous improvement across a medical device manufacturing site in a fully onsite role. You will manage tooling, tooling design, and process improvements for precision instruments used in minimally invasive robotic surgery.

The position requires RCA expertise, PFMEA background, and experience with SAP/Agile, ECO reviews, and QMS compliance.

Qualifications

• 3 years at least as Manufacturing engineer in medical device company (preferred).
• Strong RCA experience.
• Lean manufacturing tools (yellow belt is a preferred).
• Strong communications skills across team organizations and cultures.
• Strong IQ/OQ/PQ validation protocols background.
• PFMEA.
• Experience with SAP transactions and Agile.
• Review and/or approve ECO (Engineering Change Orders).

Responsabilités

• Manufacturing responsibility for tooling/fixtures, manufacturing equipment, and design improvements in production.
• Evaluate and challenge mechanism designs for reliability, functionality, and manufacturability. Provide suggested change proposals.
• Approve design releases to manufacturing, review engineering documentation, and provide vendor and in-house DFM inputs.
• Review/approve and determine the impact of ECOs from manufacturing and field perspectives.
• Take responsibility for developing and maintaining compliance with the quality system.
• Evaluate and help in the selection of suppliers for mechanical parts if required. Help resolve supplier quality issues.
• Update and revise Manufacturing Process Instructions (MPIs) to ensure accuracy and completeness
• Address line support issues as they arise
• Document and report any variances, problems, issues, or concerns on all aspects of the manufacturing process
• Provide production personnel with expectations and performance feedback regularly in the production process
• Drive improvements in safety, quality, production, and cost
• Understand, train personnel, and enforce strict adherence to the applicable Department Operating Procedures (DOPs) and Standard Operating Procedures (SOPs) of the Quality System
• Maintain up-to-date and accessible training records for MPIs and Quality System documents
• Assist in setting and attaining quarterly and annual production goals
• Learn and enforce company safety policies and practices
• Review and disposition of discrepant material in the manufacturing line. Implement corrective actions to prevent recurrences.
• Active participant in quality improvement initiatives, providing feedback to find the root cause and problem-solving.
• Design and documentation responsibilities for custom and standard production tooling/fixtures.
• Process and part design/documentation duties for cost reduction programs.

Connaissances

Manufacturing experience

RCA experience

Lean manufacturing

Communication skills

IQ/OQ/PQ validation

PFMEA

SAP

Agile

ECO review/approval

Outils

SAP

Description du poste

Intuitive is seeking a Manufacturing Engineer to lead Lean implementations and drive continuous improvement across a medical device manufacturing site in a fully onsite role. You will manage tooling, tooling design, and process improvements for precision instruments used in minimally invasive robotic surgery.

The position requires RCA expertise, PFMEA background, and experience with SAP/Agile, ECO reviews, and QMS compliance.