Process Engineer Ii (Temporary) (Tijuana)

Position

Process Engineer II – Engineering Department

Job Position Accountabilities / Expectations

1. Coordinates & Executes complex projects based on specialized knowledge.
2. Designs, proposes, and/or implements new systems that require knowledge of different continuous improvement techniques.
3. Leads or participates in cross‑functional project teams for continuous improvement and/or new product and/or process introduction, transfer, and implementation of new processes according to the client's expectations.
4. Develops, modifies, and maintains standard operating procedures of the engineering function.
5. Provides support to assigned assembly lines to improve processes, methods, or equipment.
6. Develops part analysis, DOE, and validation protocols to maintain or improve processes.
7. Trains supervisors, line leads, and/or operators on product process changes.
8. Designs fixtures, production tools, and process equipment using modeling software (CAD, SolidWorks, or others).
9. Manages projects that meet timeline, scope, and cost.
10. Contributes as a team member to the Business Unit goals to reach conformance, back‑order, and other team goals.
11. Provides support to the quality system (QNC, CAPA, MVP, VALIDATIONS, Deviations).
12. Leads 6‑sigma and Kaizen event projects to drive cost savings.
13. Identifies cost‑saving opportunities and executes lean transformation activities (e.g., modifying manufacturing flow).

Qualifications / Education / Experience / Skill Required

Required Qualifications

• Education: Engineering bachelor degree.
• Experience: At least 4 years in the Maquiladora industry with knowledge of its regulations.
• Experience in manufacturing operations of medical devices, with evidence of continued growth and successful leadership of projects achieving results in a team environment.
• Knowledge of Lean/6‑sigma tools and methodology; preferred GB certification or demonstrated use of applied statistics and VSM with experience leading Kaizen events.
• Bilingual (English/Spanish).

Preferred Qualifications

• FDA, ISO, GMP's (Good Manufacturing Practices) & validation, DOE, layouts, fixture design experience.