What are the responsibilities and job description for the Sterilization Engineer position at Transmedics Inc?
JOB DESCRIPTION
Position: Sterilization Engineer
Reports to: Director Quality Assurance
The Sterilization Engineer is responsible for leading technical project and providing operation support to terminal sterilization activities to facilitate efficient operations, to optimize existing processes, and to ensure that production, quality, and regulatory compliance goals are met, with focus on ETO process. Interfaces with research and development and/or new product development to integrate new products or processes into the existing sterilization processes.
ESSENTIAL TASKS AND DUTIES INCLUDE:
- Lead EO sterilization cycle definition, development, and validation, ensure that all corresponding activities were executed, and documentations were robust.
- Manage and execute the activities and logistics associated with EO sterilization including dunnage creation, Sample Preparation, BI placement, Palletizing and Shipment.
- Manage and coordinate sterilization validation and qualification testing activities with external laboratories for Bioburden, Product sterility test, Endotoxin, EO Residual testing and BI sterility testing.
- Understand the regulatory requirement landscape and provide technical input into company’s long term sterilization strategy.
- Support environmental monitoring process related to product sterilization.
- Perform other TransMedics tasks and duties as required
BACKGROUND AND QUALIFICATIONS:
- Minimum of 5 years relevant technical experience in EtO sterilization.
- Microbiology and environmental monitoring experience
- Medical Device industry experience
- Excellent verbal and written communication skills.
- Extensive knowledge in ISO 10993, ISO 11135, ISO 14161, ISO 11737.
- Experience with regulatory submission related to EO sterilization process preferred.
- Knowledge of ISO 14698 and ISO 14644 preferred.
- Knowledge and experience in product cycle development, validation, and maintenance.
- Knowledge and experience environmental monitoring and microbiology preferred.
- Outstanding verbal and written communication skills
- Strong sense of urgency
- Demonstrated ability to operate in a dynamic, growing environment
EDUCATION:
- BS degree in engineering, science, or technical discipline (MS preferred) or equivalent combination of education and experience
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