
Sterilization Process Engineer at Applied Medical
Rancho Santa Margarita, CA 92688
About the Job
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.
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
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
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)
- Training and mentorship with ongoing learning and development courses
- On-campus wellness activities
- Comprehensive medical and dental and vision coverage
- Education reimbursement program
- 401(k) program with discretionary employer match
- Generous vacation accrual and paid holiday schedule