Sterilization Engineer Ii

Medtronic UK

Competitive salary; short-term incentive via medtr...
Ethylene oxide sterilization experience
Iso 11135 and iso 13485 standards knowledge
Fda and pmda regulatory compliance
The Sterilization Engineer II ensures sterilization processes comply with FDA, PMDA, and ISO standards while leading validation initiatives

Job Summary

  • The Sterilization Engineer II ensures sterilization processes comply with FDA, PMDA, and ISO standards while leading validation initiatives.
  • This role involves collaborating with global teams to align strategy and executing continuous improvement projects for sterilization effectiveness.
  • Medtronic offers a competitive salary, flexible benefits package, and eligibility for the Medtronic Incentive Plan (MIP).

Matching Summary

The Sterilization Engineer II ensures sterilization processes comply with FDA, PMDA, and ISO standards while leading validation initiatives.

Salary

Competitive Salary; Short-term incentive via Medtronic Incentive Plan (MIP); Flexible Benefits Package

Skills & Requirements

Must-have

  • Ethylene Oxide sterilization experience
  • ISO 11135 and ISO 13485 standards knowledge
  • FDA and PMDA regulatory compliance
  • Validation protocol creation and execution
  • Root cause analysis and CAPA implementation

Nice-to-have

  • Master's degree in engineering or related field
  • Parametric release processing experience
  • Microbiological testing expertise
  • Cross-functional global team collaboration
  • Mentorship of less experienced engineers

Key Requirements

  • Bachelor's degree in Engineering, Microbiology, or Biotechnology
  • Minimum 2 years experience in medical device or pharmaceutical industry
  • Direct experience with EO sterilization equipment and process controls
  • Proficiency in Minitab software
  • Fluency in written and spoken English

Work Rights

Not specified

Tailored Resume

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