Senior Project Engineer

hace 1 mes


Mexicali, Baja California, México Prodensa A tiempo completo
Job Title: Senior Project Engineer

At Prodensa, we are seeking a highly skilled Senior Project Engineer to join our team.

Job Summary:

The Senior Project Engineer will be responsible for collaborating with the Engineering department to coordinate workloads, manage projects, and implement manufacturing processes and engineering changes for medical devices.

Main Responsibilities:

  • Identify and mitigate risks in manufacturing processes, ensuring compliance with safety guidelines.
  • Revalidate manufacturing processes due to changes in requirements, machinery, or replacements.
  • Collaborate with Engineering Management to provide continuous support for products and projects after implementation.
  • Provide training to personnel on new processes, assembly, and test procedures.
  • Lead processing validation, participating directly or assigning resources.
  • Work as a team member with other departments and customers.
  • Collaborate with Engineering Management as a departmental representative before internal audit groups.
  • Train departmental personnel on related procedures.
  • Provide ongoing support for products and projects after implementation.
  • Support R&D and NPI departments.
  • Attend and respond to audits.
  • Supervise engineers, new product introduction, and R&D projects.

Requirements:

  • Knowledge of production machinery and equipment.
  • Product introduction and transfers.
  • Processes validation (IQ, OQ, PQ, TQ, etc.).
  • Risk analysis and PFMEA.
  • Knowledge of ISO 13485.
  • Six Sigma, lean manufacturing.
  • Project management.
  • Personnel management.
  • Leadership.
  • Communication.
  • Teamwork.
  • Bilingual Spanish/English.
  • Engineering Degree.

What We Offer:

At Prodensa, we offer a dynamic work environment, opportunities for growth and development, and a competitive compensation package.


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