• Sterilization Process Engineer

    Position Location US-CA-Rancho Santa Margarita
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    Applied-Medical-Logo-w-Tag_H_Teal_cropped

     

    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

    Preferred

     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)

    Benefits

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

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