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Sterilization Engineer - Enfield, CT

Branch ID: 5246

Contact: cathy.wynne@staffmark.com

Pay Rate/Salary: $75,000.00 - $90,000.00

Summary:

This position is responsible for the technical execution of activities associated with projects in the global sterilization network to improve operational efficiency, ensure predictable product flow, and enable lowest total cost of ownership.

Responsibilities of Program Management:

  • Lead 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 routine 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.)

  • Knowledge of manufacturing and assembly processes.

  • Strong leadership skills.

  • Excellent verbal and written communication skills.

  • Verbal and written fluency in English.

    Technical:

  • 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 participations and/or facilitating Kaizen events using lean manufacturing principles.

  • The ability to understand a range of engineering functions and procedures.

  • A practical and logical approach to problem solving using lean six sigma concepts.

  • Interpersonal, presentation and communication skills.

  • Team working and people management skills.

  • The capacity to work well under pressure and take on new challenges.

  • Organizational and time and project management skills and the ability to work to tight deadlines and finite deliverables.

  • An awareness of health and safety issues associated to sterilization manufacturing environments.

  • Willingness and capability to travel, as required (estimated <5%).

#LI-CW1, #medicaldevices, #engineering


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.)

Job ID:
88004

Branch ID/Name:
5246

Location:
Enfield, CT

Category:
Engineering

Job Type:
Direct Hire Position
Industry
Engineering

Posted:
9/12/2018

Apply for this Position

Sterilization Engineer

City, State or Zip Code: Enfield, CT

Position Type: Direct Hire Position

Date Posted: 9/12/2018