Operations Engineering Manager

RTI Surgical
Job Description
Full-Time
Requisition ID: 1580

While this is intended to be an accurate reflection of the current job, it is not necessarily an exhaustive list of all responsibilities, skills, duties, requirements, or working conditions associated with the job.  RTI Surgical, Inc., reserves the right to revise the job or require that other or different tasks are performed when circumstances warrant (i.e., emergencies, changes in personnel or staffing, workload, or technical developments).  

 

SUMMARY: 

RTI Surgical is global, industry-leading private label OEM with expertise in allograft, xenograft and synthetic-based implants. RTI began operations in 1998 when it spun off from the University of Florida Tissue Bank in 1998 with the goal of expanding the gift of tissue donation by pioneering tissue-based innovations that promote natural healing. Today, through integrated partnerships with customers, RTI develops and delivers restorative solutions to physicians and their patients.  

 

As a Private Label Original Equipment Manufacturer (PLOEM) partner, RTI provides comprehensive turn-key services for development and product life cycle management in support of patients and leading medical technology companies. RTI’s implants are used in multiple surgical applications including dental, spine, sports medicine, plastic and reconstructive surgery, urology/urogynecology and trauma. 

 

RTI is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on four key values: 

  • We are accountable to each other by trusting each other’s judgement and hold each other responsible for results. 

  • We find joy by striving to create a working environment that people enjoy. 

  • We fully engage by focusing our hearts and minds on our customers, patients, and each other. 

  • We adapt to change by working collaboratively to be flexible to the changing needs of our business. 

RTI’s headquarters is located near Gainesville, Fla. in North Central Florida’s growing life sciences region, and has additional state-of-the-art facilities in the Greenville, N.C. and Germany. 

 

Montagu Private Equity (“Montagu”), a leading European private equity firm, acquired RTI in 2020 and have supported the transformation of the company to its next level of potential. 

  

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. 
  • Protects RTI’s 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 Requirements: 

 

Light work:  Physically handle objects up to 20 lbs. occasionally. 

 

Work Environment: 

Office Setting - Open layout with assigned work station or office 

Contact Information