Sterilization Process Engineer

Applied Medical Distribution Corporation•Irvine, CA

60d•$71,000 - $75,000

About The Position

The Sterilization Process Engineer at Applied Medical plays a vital role in ensuring the safety, quality, and compliance of medical devices through the development, validation, and optimization of sterilization processes. This position contributes to Applied Medical's mission of advancing healthcare by designing and maintaining sterilization systems that meet stringent industry standards. The Sterilization Process Engineer collaborates closely with cross-functional teams to support product innovation, manufacturing efficiency, and regulatory compliance across Applied Medical's product portfolio.

Requirements

Bachelor's degree in engineering or a scientific discipline relevant to sterilization processes or equipment (e.g., mechanical engineering, chemical engineering, or microbiology).
Ability to analyze, understand, and troubleshoot complex systems, including sterilization equipment and process controls.
Strong oral and written communication skills for documentation, technical reporting, and team collaboration.
Proven ability to develop innovative and practical solutions to complex engineering challenges.
Demonstrated ability to work independently and manage multiple projects, priorities, and deadlines.
Strong interpersonal and teamwork skills, with the ability to collaborate across engineering, production, and quality teams.

Nice To Haves

Familiarity with electron beam (e-beam) sterilization systems or comparable radiation-based technologies.
Familiarity with ethylene oxide (EtO) sterilization systems and related validation methods.
Experience programming, operating, or troubleshooting Programmable Logic Controllers (PLCs).
Experience working in a laboratory setting
Knowledge of sterilization validation standards and procedures for radiation and ethylene oxide sterilization (e.g., ISO 11135, ISO 11137).
Understanding of medical device manufacturing and quality system requirements.

Responsibilities

Develop and validate sterilization processes for new and existing medical devices, ensuring compliance with regulatory and industry standards.
Qualify, maintain, and troubleshoot electron beam sterilization systems and associated equipment to ensure optimal performance and reliability.
Qualify, maintain, and troubleshoot ethylene oxide sterilization systems and equipment to support consistent and effective sterilization cycles.
Conduct root cause analyses and develop corrective and preventive actions (CAPA) to address non-conformances and improve process control.
Generate and update engineering documentation, including drawings, quality instructions, test protocols, and validation reports.
Collaborate with production, quality assurance, and R&D teams to support continuous improvement in manufacturing and sterilization operations.
Participate in cross-functional problem-solving initiatives to improve product quality, system reliability, and regulatory compliance.
Maintain current knowledge of sterilization validation procedures, process standards, and applicable ISO and FDA guidelines.