Process Engineer: Manufacturing Optimization & Tooling

Sonova; Mexicali; Presencial; MXN 446.000 - 781.000; Jornada completa

Descripción de la vacante

Sonova Mexicali site is seeking a Manufacturing/Process Engineer to identify, develop, and implement improvements to hearing aid assembly processes. You will design jigs, fixtures, and tools, evaluate equipment, and collaborate with cross-functional teams to boost quality and efficiency.

You will create work instructions, validate new equipment on-site (IQ/OQ/PQ), and lead initiatives to monitor SPC and implement corrective actions for non-conforming materials.

Formación

• Engineering degree and strong regulatory awareness (FDA QSR; ISO 13485 preferred).
• Minimum 3 years in manufacturing or process engineering.
• Experience creating process work instructions for manufacturing operations.
• Proficiency with Process Validation Protocols and Transfer Plans.
• Experience with SPC, PFMEA, and corrective actions.
• Ability to design and implement tooling and equipment for assembly.
• Excellent collaboration and communication in cross-functional teams.

Responsabilidades

• Identify, develop, and implement improvements to manufacturing processes.
• Investigate and resolve process-related issues for internal and external customers.
• Lead on-site validation (IQ/OQ/PQ) of new equipment and processes.
• Design jigs, fixtures and tools to support hearing aid assembly.
• Create and maintain process work instructions and documentation.
• Collaborate cross-functionally to ensure project success and continuous improvement.
• Monitor production data and implement corrective actions for non-conforming materials.

Conocimientos

Process improvement

Cross-functional collaboration

Data-driven problem solving

FDA QSR compliance

SPC experience

pFMEA development

Process validation

Root cause analysis

Attention to detail

Microsoft Office

Corel Draw knowledge

Educación

Bachelor’s degree in Industrial, Mechanical, or Electrical Engineering

Herramientas

Corel Draw

Microsoft Office Suite

Descripción del empleo

Sonova Mexicali site is seeking a Manufacturing/Process Engineer to identify, develop, and implement improvements to hearing aid assembly processes. You will design jigs, fixtures, and tools, evaluate equipment, and collaborate with cross-functional teams to boost quality and efficiency.

You will create work instructions, validate new equipment on-site (IQ/OQ/PQ), and lead initiatives to monitor SPC and implement corrective actions for non-conforming materials.