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Job Title:  Operations Engineer

Req ID:  26210
Job Category:  Manufacturing Operations

Mentor, OH, US, 44060

Description: 

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

Position Summary

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

STERIS' sterilization solutions help protect our customers' valuable surgical instruments to increase their productivity and help enhance patient and personnel safety. The Operations Engineer works within one of several manufacturing plants in Mentor, Ohio that focuses on sterility assurance. In this role you will direct and supervise maintenance and document control over new and existing equipment. Additionally, you will manage the work of maintenance professionals and document controllers who will work with you to maintain all documentation, equipment, facility maintenance and calibration activities. As you manage implementation and maintenance of equipment, you will lead a wide variety of projects to ensure the transition into manufacturing. These include new equipment procurement, installation, new product launches, equipment validation and calibration, current product support, cost savings initiatives and LEAN activities. You will also ensure compliance to design controls, ISO, cGMP’s, OSHA and corporate policies.

Hours: 7:00am-4:30pm

Duties

  1. Define and participate in the development of projects to implement or improve manufacturing efficiency and ensure compliance during manufacturing and design transfer.
  2. Plan, organize, prioritize the work of the maintenance technicians and document control coordinator.
  3. Identify resource needs and monitor project and department budgets.  Maintain a close liaison with R&D, Quality, Marketing and Manufacturing personnel to implement approved development and improvement projects.
  4. Manage and direct activities associated with the development process for projects assigned to your area of responsibility including required validation testing, procedures and drawings.
  5. Comply with all applicable cGMP, ISO and OSHA regulations.
  6. Coordinate all facility maintenance activities. Manage and direct all Contractors to ensure adherence to guidelines.
  7. Prepare and conduct formal program reviews for management. Primary person responsible for maintaining a dynamic file on all projects, and ensure these projects are proceeding in accordance with regulatory requirements.
  8. Prepare presentations with appropriate data and conclusions.
  9. Support plant Continuous Improvement activities.
  10. Maintain all manufacturing, QA, and facility equipment through calibrations, PM’s and general facility maintenance.
  11. Establish production rates and cost for manufacturing through time studies.  

Duties - cont'd

Education Degree

  • Bachelor's Degree

Required Experience

  • 4+ years engineering experience in a manufacturing environment, within a regulated industry.
  • Experience purchasing, implementing, validating and calibrating capital equipment.
  • Experience leading and directing technician’s day to day work.

Preferred Experience

  • Knowledge of Design Controls, cGMPs, AutoCad and MS literacy.
  • Statistical data base literacy.

Skills

 

STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics.  We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16,000 associates and Customers in more than 100 countries.

STERIS strives to be an Equal Opportunity Employer.  

Req ID:  26210
Job Category:  Manufacturing Operations

Mentor, OH, US, 44060


Nearest Major Market: Cleveland
Nearest Secondary Market: Akron

Job Segment: Operations Manager, Manufacturing Engineer, Engineer, QA, Operations, Engineering, Quality