Sterilization Process Engineer

Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions.

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.

• 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.

• Delivering validated, reliable sterilization processes that ensure product safety and meet global regulatory requirements.
• Collaborating effectively with cross-functional engineering and manufacturing teams to support high-quality medical device production.
• Proactively identifying process improvements that enhance efficiency, reduce downtime, and improve compliance outcomes.
• Demonstrating technical expertise and problem-solving skills in troubleshooting sterilization systems and optimizing performance.
• Maintaining accurate and compliant engineering documentation that supports audits, validations, and continuous improvement efforts.

This position requires the following skills and attributes:

• 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.

The following skills and attributes are preferred:

• 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…