Onsite Supplier Process Engineer Med Device Quality

Intuitive; Mexicali; Presencial; MXN 1.531.000 - 2.212.000; Jornada completa

Descripción de la vacante

Intuitive Mexicali-based Supplier Engineering role focused on sustaining activities for Instruments & Accessories, reporting to the Supplier Engineering Manager. You will work with external suppliers and internal teams to improve performance and resolve issues at the Mexicali plant.

The role requires engineering exp. in medical devices, GD&T proficiency, and travel to supplier sites as needed. Bachelor’s in EE/ME; 5 years of related experience; Six Sigma/Lean knowledge a plus.

Formación

• Engineering and manufacturing experience with plastic injection molding, metal injection molding (MIM), or machined metal components.
• Background in Supplier Quality, Supplier Development, or related fields preferred.
• Strong English written and verbal communication skills (advanced level).
• Excellent interpersonal and leadership abilities.
• Proven project management capabilities.
• Skilled in stakeholder alignment and conflict resolution.
• Strong analytical and problem-solving skills along with good judgment.
• Ability to travel to suppliers on an as-needed basis – domestic and international.

Responsabilidades

• Lead resolution of supplier-related issues from initial symptoms through root cause analysis and corrective action, including CAPA/SCAR documentation.
• Drive supplier investigations and implement corrective and preventive actions to eliminate recurrence.
• Evaluate supplier actions and identify opportunities for continuous improvement.
• Initiate and manage changes to specifications and drawings through the engineering change order process.
• Manage supplier changes including process optimization, facility updates, equipment qualification, and line validations.
• Collaborate with suppliers and internal teams to define deliverables and timelines.
• Complete qualification deliverables such as Supplier pFMEA, FAIR, IQ/OQ/PQ validations, inspection reports, Gage R&R, and process capability analysis.
• Lead cross-functional teams to resolve complex process challenges.
• Provide technical support for failure analysis of production components, assemblies, and field returns.
• Prioritize and manage multiple concurrent projects effectively.
• Communicate project status clearly to internal and external stakeholders.
• Execute cost reduction, capacity improvement, and risk mitigation initiatives with suppliers.
• Monitor and drive achievement of key metrics in quality, cost, and responsiveness.
• Develop suppliers to excel in KPIs, including quality ownership, capacity, and sub-tier management.
• Provide data-driven supply base information to management with little guidance.
• Influence and guide Engineering in choosing suppliers by determining selection criteria for preferred suppliers.

Conocimientos

Advanced English

Project Management

Leadership

Analytical Thinking

Problem Solving

Stakeholder Alignment

Cross-functional Collaboration

GD&T (Geometric Dimensioning &

Supplier Quality

Educación

BS in Electrical Engineering

BS in Mechanical Engineering

Six Sigma

ISO 13485 knowledge

Herramientas

SAP

CAD

Minitab

ERP systems

Descripción del empleo

Intuitive Mexicali-based Supplier Engineering role focused on sustaining activities for Instruments & Accessories, reporting to the Supplier Engineering Manager. You will work with external suppliers and internal teams to improve performance and resolve issues at the Mexicali plant.

The role requires engineering exp. in medical devices, GD&T proficiency, and travel to supplier sites as needed. Bachelor’s in EE/ME; 5 years of related experience; Six Sigma/Lean knowledge a plus.