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Operations Engineering Manager
Infrahire Alachua, FL
$139k-170k (estimate)
Full Time 5 Days Ago
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Infrahire is Hiring an Operations Engineering Manager Near Alachua, FL

Operations Engineering Manager in Alachua, FL
Responsibilities
  • Responsible for coordinating activities focused on reliable operation of all critical production support systems and the integrity of infrastructure for the Alachua production site.
  • Collaborates with Planning, Engineering and Quality staff to ensure realization of an effective organization and promote strategic objectives to achieve and maintain World Class standards.
  • Ability to realize revenue through effective utilization of resources.
  • Fosters team environment to improve efficiency of the maintenance program and develop depth in technical excellence.
  • Manages by influence to achieve goals in collaboration with critical company functions.
  • Improves reliability and strategically expand our production base as needed to support revenue goals.
  • Ensures the quality and integrity of current process areas, critical systems and related infrastructure in Alachua.
  • Works with site operations leadership and new product development to assist in ensuring operations readiness for the orderly and efficient implementation of new processes into production.
  • Provides clear, consistent and measurable direction regarding timelines and deliverables.
  • Manage packaging engineering activities required for the development, verification and validation (process & development) of market released product per ISO 11607
  • Coordinate the submission of packaging development requests and prioritizes according to company goals
  • Direct and manage the daily activities and workflow of packaging engineers
  • Define the quality objectives/requirements for incoming and in-process packaging materials
  • Oversee and implement controlled environmental programs for ISO Class 7 Controlled Environment Areas per ISO 14644
  • Identify product cleaning requirements for instruments that conform to ISO 17664 standards
  • Establish industry accepted validated steam sterilization parameters per ISO 17665 and ST79 guidance
  • Established validated gamma sterilization for various product types per ISO 11137.
  • Complete biocompatibility studies in accordance to ISO 10993 for instruments and implants
  • Provide guidance to the development of cleanable instruments to conform to ISO 17664
  • Develop packaging process controls to achieve consistent and predictable outcomes
  • Train new employees on packaging quality assurance practices
  • Champion proactive quality assurance activities throughout operations and with suppliers
  • Participate in non-project related activities to achieve corporate goals
Core Competencies
  • Understanding of equipment to ensure that it is properly designed, selected, installed and maintained based on a life-cycle philosophy of an asset
  • Able to administer the condition-based maintenance program and be responsible for vibration, ultrasonic and thermography data analysis.
  • Provides technical guidance and supervision of all preventive and predictive maintenance programs, critical equipment analysis and condition monitoring techniques.
  • Develops standards and plans for major engineering and packaging projects.
  • Administers contracts for the provision of supplies and services.
  • Participates in the development and implementation of test plans, validations, SOPs, work instructions and other technical documentation as necessary.
  • Collaborates with Management at all satellite locations to ensure that maintenance and reliability standards are consistent across all sites.
Education/Experience Required
  • Vocational Training Preferred
  • Bachelor's Degree in Engineering Required
  • Minimum 5 years supervisory experience
Physical RequirementsLight work: Physically handle objects up to 20 lbs. occasionally.
Work EnvironmentOffice Setting - Open layout with assigned work station or office

Job Summary

JOB TYPE

Full Time

SALARY

$139k-170k (estimate)

POST DATE

06/05/2024

EXPIRATION DATE

07/02/2024

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