Process Engineer

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

This position is responsible for identifying, developing, and implementing improvements to existing manufacturing processes and methods. The role also includes recommending appropriate equipment and developing jigs, fixtures, and tools to support the efficient assembly of hearing aids. A strong emphasis is placed on collaboration and contributing to team success.

Key Responsibilities:

• Investigate and resolve process-related issues identified by internal and external customers.
• Drive continuous improvement by identifying, developing, and implementing enhancements to manufacturing processes.
• Improve product quality by implementing process and method optimizations.
• Design and develop jigs, fixtures, and tools to support hearing aid assembly.
• Recommend equipment and technologies to enhance production efficiency.
• Create and maintain process work instructions and documentation.
• Lead or participate in the implementation of new equipment and processes, including on-site validation (IQ/OQ/PQ), staff training, and documentation updates.
• Collaborate cross-functionally to ensure project success and continuous improvement.

Qualifications & Skills:

• Bachelor’s degree in Industrial, Mechanical, or Electrical Engineering.
• Solid knowledge of FDA QSR regulations; experience with ISO 13485 standards is strongly preferred.
• Minimum of 3 years of experience in a similar manufacturing or process engineering role.
• Proven experience creating and maintaining process work instructions for manufacturing operations, including assembly and in-process acceptance procedures.
• Proficient in developing and executing Process Validation Protocols and/or Transfer Plans, including generating comprehensive test reports.
• Skilled in process risk assessments, including pFMEA development and maintenance.
• Supports investigation, disposition, and implementation of corrective actions for non-conforming materials.
• Experience establishing and monitoring statistical process controls (SPC) in production environments.
• Strong attention to detail and ability to work independently or collaboratively in cross-functional teams.
• Demonstrated problem-solving abilities with a structured and data-driven approach.
• Proficient in Microsoft Office Suite; working knowledge of Corel Draw.

Soft Skills & Competencies:

• High learning agility and adaptability to new challenges.
• Strong interpersonal skills with the ability to collaborate effectively and respectfully in diverse teams.
• Able to present ideas clearly, actively listen, and contribute to group decision-making.

Additional Responsibilities:

• Participate in the design or redesign of tools and equipment to improve manufacturing processes.
• Ensure employee safety and compliance with health and safety regulations.
• Monitor, test and maintain production equipment to ensure operational efficiency.
• Collect and analyze production data for continuous improvement.
• Support cost control initiatives and contribute to maintaining operations within budget.