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Applied Medical · 2 months ago

Sterilization Process Engineer

Irvine, CA

Full-time

Onsite

Mid Level

$71K/yr - $75K/yr

Applied Medical is a new generation medical device company committed to innovation and excellence in healthcare. The Sterilization Process Engineer plays a vital role in ensuring the safety and compliance of medical devices through the development and optimization of sterilization processes, collaborating with cross-functional teams to support product innovation and regulatory compliance.

BiotechnologyHealth CareMedicalMedical Device

H1B Sponsor Likely

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

Qualification

Sterilization process developmentRegulatory compliance knowledgeTroubleshooting sterilization systemsBachelor's degree in engineeringElectron beam sterilizationEthylene oxide sterilizationProgramming PLCsTechnical reportingTeam collaborationProblem-solving skills

Required

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

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

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.

Company

Applied Medical

Glassdoor3.2

As a new generation medical device company, Applied Medical is focused on meeting three fundamental healthcare needs: enhanced clinical outcomes, cost containment and unrestricted choice.

Founded in 1987

Rancho Santa Margarita, California, USA

5001-10000 employees

http://www.appliedmedical.com

H1B Sponsorship

Applied Medical has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (37)

2024 (32)

2023 (23)

2022 (34)

2021 (18)

2020 (12)