Medical Device Sterilization Engineer - Enfield, CT
Branch ID: 5246
Pay Rate/Salary: At least: $85,000.00
This newly created position is responsible for the hands-on execution associated with projects in Class II and Class III Medical Device sterilization to improve operational efficiency, ensure predictable product flow and enable overall lowest total cost of program.
Lead new product development review and approval of sterilization validations and product adoptions.
Provide technical support for in-house ethylene oxide and moist heat sterilization, maintaining flow of development and commercial products.
Develop and optimize sterilization cycles with the intent of improving cycle times, reducing lead times, and sterilization of new products.
Oversee bioburden and environmental monitoring programs.
Develop Standard Operating Procedures, Manufacturing Work Instructions, Test Methods and provide on-site training to applicable technical staff.
Establish preventive maintenance program for sterilization, requalification, product loading, and material handling.
Assure compliance with Federal, State and local safety/environmental regulations. Assist in environmental testing and reporting.
BS in Engineering; Chemical, Mechanical, Biomedical or equivalent.
3+ years in medical device sterility assurance, sterilization operations or testing environment.
In depth knowledge of industrial sterilization modalities (i.e. Ethylene Oxide and Moist Heat sterilization).
Expert knowledge of GMP compliance (FDA, BS/EN, ANVISA, etc.)
Previous experience with Class II Single-Use and Class III Medical devices preferred.
Strong computer skills, including the MS Office suite and MS Project.
Must be able to fully interpret technical drawings, blueprints, specifications, illustrations, and written documents.
Experience associated with continuous improvement activities, including participation and/or facilitating Kaizen events using lean manufacturing principles.
Strong leadership skills.
Excellent verbal and written communication skills.
Verbal and written fluency in English.
BS in Engineering - Chemical, Mechanical, Biomedical or equivalent. 3+ years in medical device sterility assurance, sterilization operations and/or testing environment. In depth knowledge of industrial sterilization modalities (i.e. Ethylene Oxide and Moist Heat sterilization). Expert knowledge of GMP compliance (FDA, BS/EN, ANVISA, etc.)
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Medical Device Sterilization Engineer
City, State or Zip Code: Enfield, CT
Position Type: Direct Hire Position
Date Posted: 10/10/2018