Process Engineer

Foxconn Baja California, S.A. de C.V.

Tijuana, Baja California

Febrero 19 2026

Corporativo

Giro

Manufacturera

Actividad principal

Electronics & MedTech

Número de empleados

5000

Sitio Web corporativo

Sitio Web

Descripción y detalle de las actividades

Key Responsibilities

Design, develop, and optimize manufacturing processes for medical devices.
Lead process validation activities (IQ, OQ, PQ, and PPQ).
Characterize, scale, and strengthen processes using DOE, SPC, Six Sigma, and Lean principles.
Perform process FMEA, root cause analysis, and problem-solving to improve process capability (CpK ≥ 1.33).
Coordinate process transfers from R&D to production, ensuring manufacturability and regulatory compliance.
Collaborate with Quality and Regulatory teams to integrate process controls into the QMS and support regulatory submissions (e.g., 510(k)).
Implement continuous improvement initiatives focused on efficiency, cost reduction, and cycle time improvement.
Oversee qualification of equipment, tooling, and external suppliers.
Provide technical support for New Product Introduction (NPI) activities.
Mentor and support junior engineers, promoting best practices and knowledge transfer.

Experiencia y requisitos

Experience

Minimum of 3 years of experience in process engineering within the medical device industry.
Proven experience in process validation, technology transfer, and manufacturing scale-up.
Direct involvement in New Product Introduction (NPI) projects.
Experience working in FDA-regulated environments; Class II or III medical devices preferred.

Education

Bachelor’s degree in Mechanical, Biomedical, Chemical Engineering, or a related field.
Master’s degree and/or Six Sigma Black Belt certification preferred.

Skills and Competencies

Strong knowledge of Lean Manufacturing and Six Sigma methodologies.
Proficiency with DOE, SPC, and statistical analysis tools (e.g., Minitab).
Solid understanding of regulatory standards such as 21 CFR 820 and ISO 13485.
Advanced English (written and verbal) is required for technical communication with global teams and customers.
Strong analytical and data-driven problem-solving skills.
Effective communication and collaboration skills in cross-functional environments.
Technical leadership, mentoring capability, and ability to manage multiple projects in dynamic settings.

Beneficios

Número de vacantes 1

Área Ingeniería

Contrato Temporal

Modalidad Presencial

Turno Diurno

Jornada Tiempo Completo

Horario

Estudios Carrera con título profesional

Inglés Hablado: Avanzado, Escrito: Avanzado

Disponibilidad p. viajar No