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Job Title:  Operations Engineer

Req ID:  23264
Job Category:  Engineering
Country/Region:  US
State:  OH
City:  Mentor
Zip:  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.

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 $3B, publicly traded (NYSE: STE) organization with approximately 12,000 associates worldwide and operates in more than 100 countries.

If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status.

STERIS is an Equal Opportunity Employer.  We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law.  We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.

The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.


Nearest Major Market: Cleveland
Nearest Secondary Market: Akron

Job Segment: Operations Manager, Manufacturing Engineer, Medical, Engineer, Operations, Engineering, Healthcare