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Medical Device Sterilization Engineer - Enfield, CT

Branch ID: 5246

Pay Rate/Salary: $70,000.00 - $95,000.00

Medical Device Sterilization Engineer

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:
Medical Device Sterilization Development experience.

About Staffmark

The Company supports affirmative action and equal employment opportunity. The Company will provide equal employment in employment practices to all applicants for employment. Employment decisions shall be made without regard to any protected characteristic such as, but not limited to, race, color, religion, gender, age, disability, national origin, ancestry, citizen status, gender identity, sexual orientation, marital status, status in regard to public assistance, disabled veterans, recently separated veterans, Armed Forces service medal veterans and other protected veterans, genetic information and other legally protected classes. Furthermore, the Company is an E-Verify employer. Information provided on this application will not be used for any discriminatory purposes. The Company complies with all applicable federal, state and local non-discrimination laws and regulations. The Company will provide reasonable accommodations in the application or interviewing process. If you need a reasonable accommodation in the application or interviewing process, please contact us.

Job ID:
91985

Branch ID/Name:
5246

Location:
Enfield, CT

Category:
Engineering

Job Type:
Direct Hire Position
Industry
Engineering

Posted:
11/21/2018

Apply for this Position

Medical Device Sterilization Engineer

City, State or Zip Code: Enfield, CT

Position Type: Direct Hire Position

Date Posted: 11/21/2018