Medical Device Biocompatibility & Sterilization SME

Minneapolis, MN

Industry: Medical Device Job Number: 133620

 

Medical Device Biocompatibility & Sterilization SME

Environment:

Our client is a large medical device manufacturer. They’ re in need of a consultant strong in Biocompatibility, Sterilization & Environmental Controls.  

Duties/Responsibilities/Scope of Work

This individual will come from a Medical Device background, and must have strong, hands-on experience in  Biocompatibility for Medical Device manufacturing, as well as Sterilization (Gamma/EBEAM/EO). This individual will be building/sustaining the Micro Bio program.

 

This person will participate in New Product Development and Life Cycle Management projects within the ralm of end to end sterility assurance to develop, support and conduct catheter and accessory product design verification testing, process and sterilization validation other routine quality processes to ensure compliance with company Quality system policies, procedures, standards (FDA, ISO 13485, CMDCAS, PMDA) and other worldwide regulatory agencies that pertain to medical devices.

 

This person must have experience with any combination of EO, Sterilization, GAMMA Sterilization or  E-Beam/Radiation sterilization. Ten years of experience within microbiology, Bioburden testing, ETO, Sterilization, analystical testing and environmental monitoring. Our client will lean on this person to perform sterilization and biocompatibility activities, properly document and record necessary data/information and report it back to them efficiently.  Specific responsibilities will include initiating  and completing Biocompatibility Evaluations, chemical characterization,  determining  which Biocompatibility Tests are required, sending out samples for testing, writing  Biocompatibility Protocols & Reports, etc. 

Required Experience:
  • Medical Device 
  • Biocompatability (Must have)
  • Sterilization for Medical Device (EO, Gamma, E-Beam)
  • Writing Sterilization Testing Rationale
  • Statistical Testing
  • Environmental Monitoring
  • Bioburden Testing

Job Type: Contract 

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