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Project Manager, Device Reprocessing and Sterilization

Redwood City, CA

Project Co-Ordinator/Project Manager – Device Reprocessing & Sterilization

CORE RESPONSIBILITIES

  • Support on the disinfection and sterilization reprocessing reliability efforts for medical equipment
  • Manage the reprocessing validation efforts with third party lab
  • Work on releasing the reliability validation protocol, coordinate with the 3rd party lab on the testing, release internal reports by appropriate department, work with regulatory team on the deliverables.

 

QUALIFICATIONS (Education, Experience, Certifications)

  • Bachelor’s degree or Master’s degree in Engineering (Biomedical, Mechanical, Electrical) – 6+ yrs. of work experience OR RELATED
  • Minimum of 5 years of experience working in medical device industry
  • Familiarity with US and international (OUS) medical device cleaning, disinfection, and sterilization standards such as AAMI TIR 12, TIR30, ISO 11135, ISO 11137, AAMI TIR 28
  • Project management experience involving co-ordination with third party labs for testing and sterilization
  • Must have medical device cleaning validation & sterilization validation experience
  • Experience working with endoscopes will be a plus
  • Must have working knowledge ISO 13485, ISO 14971
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