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Medical Device Sterilization Engineer - Enfield, CT

Branch ID: 5246

Contact: cathy.wynne@staffmark.com

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.

Responsibilities:

  • 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.

Requirements:

  • 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.

#LI-CW1


Requirements:
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.)

Job ID:
89633

Branch ID/Name:
5246

Location:
Enfield, CT

Category:
Engineering

Job Type:
Direct Hire Position
Industry
Engineering

Posted:
10/10/2018

Apply for this Position

Medical Device Sterilization Engineer

City, State or Zip Code: Enfield, CT

Position Type: Direct Hire Position

Date Posted: 10/10/2018