Terumo Neuro · 1 day ago
Specialist, Product Sterilization
Aliso Viejo, CA
Full-time
Onsite
Mid Level
$76K/yr - $95K/yr
4+ years expTerumo Neuro is focused on providing innovative medical products, and they are seeking a Specialist in Product Sterilization. The role involves supporting quality assurance projects related to sterilization validation, conducting revalidations, and providing technical support for sterilization processes and environmental control activities.
Medical Device
Responsibilities
Conduct revalidations for steam, Ethylene Oxide, and radiation sterilization processes. Work closely with Operations and Quality Engineering teams to coordinate and execute revalidation activities
Conduct technical justifications and physical studies for adoption of new products into existing sterilization cycles, including, but not limited to, sterilization validation, endotoxin level testing (LAL), product bioburden testing, and residual testing
Generate project plans, validation master plans, test protocols, and reports for sterilization validation
Coordinate microbiological testing of validation samples with in-house and outside laboratories
Work with new product development teams on establishing sterilization strategies for steam, radiation, and ethylene oxide sterilization
Support cycle development activities for sterilization processes, including, but not limited to: Determine loading configurations. Determine sterilization cycle parameters based on fractional cycle approach. Identify appropriate PCD configurations, resistance hierarchy, and required quantity for validation
Provide sterilization expertise during interface with regulatory agencies, including FDA and ISO
Support clean room monitoring and validation activities, including, but not limited to, microbial, particulate, and pressure differential testing
Manage sample inventories for real time and accelerated aging studies to support Design Quality/R&D projects
Provide expertise and write-ups to support NCRs and/or CAPAs
Perform other duties as assigned
Qualification
Required
Bachelor's degree in related field or equivalent
A minimum of four (4) years of related professional experience
Understanding of ISO and FDA requirements for medical product sterilization and for cleanroom monitoring
EN ISO 11135, EN ISO 11137, EN ISO 17665, EN ISO 14644, EN ISO 14698, etc
Working knowledge of various sterilization processes including steam, heat, radiation, ethylene oxide
Experience working with biological indicators (BI's) and preparing validation samples
Technical writing abilities, including test protocols, reports, and justification documents
Ability to program and extract data from temperature/pressure data loggers
Ability to operate sterilization equipment
Experience working with laboratory testing vendors
Strong written and verbal communication skills
Ability to manage multiple projects simultaneously, stay organized, effectively manage obstacles, and drive projects to completion
Ability to actively collaborate with other departments
Proficient computer skills including MS Word, Excel, Teams, Outlook, and data logging software
Preferred
Advanced degree in a related field of study
Skills in generating write-ups to support NCRs and/or CAPAs
Advanced degree in related discipline
Certifications in related discipline (ex. CISS)
Company
Terumo Neuro
We’re in business to create and deliver innovations that redefine what’s possible in neurovascular treatment, meaningfully advancing both physician practice and patient outcomes.
1001-5000 employees
H1B Sponsorship
Terumo Neuro 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 (13)
2024 (15)
2023 (7)
2022 (14)
2021 (8)
2020 (9)
Funding
Current Stage
Late StageCompany data provided by crunchbase