MicroVention-Terumo · 4 months ago
Specialist, Product Sterilization (Temporary, 6-8 month contract)
Aliso Viejo, California, USA
Full-time, Contract
Onsite
Mid Level
$36.50/hr - $40/hr
4+ years expMicroVention-Terumo is a company focused on quality assurance in the medical device industry. They are seeking a Specialist in Product Sterilization to support quality assurance projects and activities related to sterilization validation requirements for medical products.
Health CareManufacturingMedicalNeuroscience
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
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
MicroVention-Terumo
MicroVention is now Terumo Neuro.
1001-5000 employees
H1B Sponsorship
MicroVention-Terumo 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 StageTotal Funding
$51.6MKey Investors
Crosspoint Venture PartnersU.S. Venture PartnersAdvanced Technology Ventures
2006-02-28Acquired
2003-09-04Series D· $10M
2002-08-30Series D· $19M
Leadership Team
A
Amy L. Walters
Vice President, Global Clinical Research
Rob Greene
Senior VP, R&D
Recent News
Google Patent
2025-05-06
Google Patent
2025-05-06
Company data provided by crunchbase