Sterilization Process Engineer

Position Location US-CA-Rancho Santa Margarita




Sterilization Process Engineer


Applied Medical is a rapidly growing, global organization that develops, manufactures and distributes medical devices to more than 75 countries. Our driving purpose is to satisfy the three fundamental healthcare needs: enhanced clinical outcomes, outstanding value and unrestricted choice. For 30 years, Applied Medical has been at the forefront of innovation and technology. As a result of our highly vertically integrated business model, we control all of our processes in-house, from R&D concept to clinical implementation. Applied Medical engineers take a hands-on approach, utilizing in-house cutting-edge technologies, such as automation and robotics, advanced metal processing, injection molding, and rapid prototyping. We invest heavily in R&D, advanced technologies and most importantly – the growth of our team members.

Applied Medical is proud to have a culture firmly grounded in teamwork, collaboration and regulatory compliance, while providing opportunities for growth and choice in individual career paths.

Position Description

As a Sterilization Process Engineer, you will be responsible for working within the framework of a team and performing the following activities:

  • Developing and validating sterilization processes for new and existing products
  • Qualifying, maintaining, and troubleshooting electron beam sterilization system and associated equipment
  • Qualifying, maintaining, and troubleshooting ethylene oxide sterilization system and associated equipment
  • Reviewing and evaluating non-conformances, performing root cause analysis, and proposing corrective/preventive actions
  • Generating and updating engineering documents such as drawings, manufacturing/quality instructions, test methods, and test protocols/reports
  • Working closely with production staff and other cross-functional teams
  • Other duties as assigned

Position Requirements

This position requires the following skills and attributes:

  • BS in Engineering or scientific discipline relevant to sterilization process or equipment
  • Ability to understand, analyze, and troubleshoot complex systems
  • Effective oral and written communication skills
  • Ability to develop innovative solutions to complex problems
  • Ability to work effectively in cross-functional teams
  • Ability to work independently and manage multiple tasks and priorities


 The following skills and attributes are preferred:

  • Familiarity with electron beam systems or similar equipment
  • Familiarity with ethylene oxide systems or similar equipment
  • Experience with Programmable Logic Controllers (PLCs)
  • Experience in sterilization validation procedures and standards (radiation and ethylene oxide)
  • Understanding of manufacturing and quality standards
  • Working knowledge of CAD modeling and drafting (i.e. Solid Works)


  • Training and mentorship with ongoing learning and development courses
  • On-campus wellness activities
  • Comprehensive medical and dental and vision coverage
  • Education reimbursement program
  • 401(k) program with discretionary employer match
  • Generous vacation accrual and paid holiday schedule


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