Sustaining Center Mechanical Engineer

FRESENIUS MEDICAL CARE

Reynosa, Mexico
Bs in mechanical engineering required
2-5 years sustaining or manufacturing experience
Fda and iso regulatory compliance knowledge
This role manages product changes, refurbishment programs, and hardware configuration while ensuring full compliance with FDA and ISO standards

Job Summary

  • This role manages product changes, refurbishment programs, and hardware configuration while ensuring full compliance with FDA and ISO standards.
  • The engineer will lead engineering changes, perform root cause analysis for production issues, and support manufacturing transfers at the Reynosa facility.
  • Candidates must collaborate with global teams to validate testing methods and drive cost reduction initiatives within a regulated medical device environment.

Matching Summary

This role manages product changes, refurbishment programs, and hardware configuration while ensuring full compliance with FDA and ISO standards.

Skills & Requirements

Must-have

  • BS in Mechanical Engineering required
  • 2-5 years sustaining or manufacturing experience
  • FDA and ISO regulatory compliance knowledge
  • Hardware configuration management expertise
  • Root cause analysis and troubleshooting skills

Nice-to-have

  • Master's degree in Engineering preferred
  • Electromechanical or Mechatronics background
  • Hands-on soldering capabilities
  • SAP software proficiency
  • Bilingual English and Spanish speaker

Key Requirements

  • Bachelor of Science in Mechanical Engineering
  • 2–5 years of relevant industry experience
  • Experience in regulated medical device industries
  • Fluency in English and Spanish languages

Work Rights

Not specified

Tailored Resume

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