Sterilization Process Engineer

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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.

position Description

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.

Key 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.

Success in This Role Looks Like

• 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.

Position Requirements

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.

Preferred

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 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.

Benefits

• Competitive compensation range: $71000 – $75000 / year (California).
• Comprehensive benefits package.
• Training and mentorship opportunities.
• On-campus wellness activities.
• education reimbursement program.
• 401(k) program with discretionary employer match.
• Generous vacation accrual and paid holiday schedule.

Please note that the compensation range may be based on factors such as relevant education, qualifications, experience. The compensation range may be adjusted in the future, and special discretionary bonus or incentive compensation plans may apply.

Our total reward package reflects our commitment to team member growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life.

Equal Opportunity Employer

Applied Medical is an Equal Employment Opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other basis protected by federal, state or local laws in the locations where Applied Medical operates.

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