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Principal Sterilization Engineer

3 months ago

Cleveland, United States BioTalent Full time

The Role:

Our client, a world-renowned medical device manufacturer, is looking for an experienced Sterilization Engineer as the local SME in their Cleveland, MS facility.



Must Haves:

  • Bachelor’s Degree in Engineering Required (Mechanical, Industrial, Electrical, Chemical, or Computer degrees are preferred).
  • 7+ years Engineering / Manufacturing experience preferred.
  • Programming/troubleshooting experience with automation controls, automated assembly, control systems (PLC’s, HMI’s, servo’s, valves, regulators, and associated instrumentation) is desirable.
  • Six Sigma Master Black Belt Certification or industry standard equivalent is desirable.


Responsibilities:

  • Design/develop product sterilization equipment and processes.
  • Manage numerous projects with minimal supervision.
  • Prepare estimates for various tasks and projects.
  • Lead capital projects both directly and through coordinating engineers.
  • Drive Continuous Improvement Activities.
  • Collaborate with plant and corporate groups as well as contractors and vendors.
  • Lead start-up, debug, and commission new manufacturing processes.
  • Sterilization equipment life cycle management including upgrades, replacement, and decommissioning.
  • Product life cycle management including product design changes, material changes, Supplier Notice of Change (SNC) assessments, specification changes, etc.
  • Provide technical support/troubleshooting to all plant departments.
  • Demonstrate proactive communication and problem solving.
  • Responsible for supporting and achieving Value Improvement Projects (VIP’s).
  • Responsible for adhering to FDA Design Control standards at all times.
  • Responsible for adhering to and maintaining all department Standard Operating Procedures (SOPs), forms, and log books.



On Offer:

  • 4 Weeks PTO
  • Relocation Assistance
  • 401K Match
  • Employee Stock Purchase Program
  • Paid Parental Leave
  • Medical, Dental and Vision
  • Tuition Reimbursement