Sterilization Engineer Ii

Medtronic

Competitive salary; short-term incentive via mip; ...
Not specified (considering the nature of the role, it may involve a hybrid approach).
Ethylene oxide sterilization experience
Iso 11135 and iso 13485 standards knowledge
Fda and pmda regulatory compliance
Medtronic is seeking a Sterilization Engineer II to ensure compliance with sterilization processes, particularly Ethylene Oxide (EO), according to various regulatory and quality system standards. The role involves leading validations, process improvements, and collaborating with global teams, while providing technical support and ensuring optimal performance of sterilization equipment

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 standardize sterilization protocols and overseeing equipment requalification and calibration.
  • Medtronic offers a competitive salary, flexible benefits package, and eligibility for the Medtronic Incentive Plan (MIP).

Matching Summary

Match Score: 85

Medtronic is seeking a Sterilization Engineer II to ensure compliance with sterilization processes, particularly Ethylene Oxide (EO), according to various regulatory and quality system standards. The role involves leading validations, process improvements, and collaborating with global teams, while providing technical support and ensuring optimal performance of sterilization equipment.

Salary

Competitive Salary; Short-term incentive via 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

  • Advanced degree in engineering or microbiology
  • Parametric release processing experience
  • Minitab software proficiency
  • Cross-functional global team collaboration
  • Microbiological testing knowledge

Key Requirements

  • Bachelor's degree in engineering or equivalent
  • Minimum 2 years in medical device industry
  • Direct EO sterilization equipment experience
  • Master's degree reduces experience requirements

Work Rights

Not specified

Tailored Resume

Cover Letter