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Job Title:  Operations Project Engineer

Req ID:  21448
Job Category:  Manufacturing Operations
Country/Region:  US
State:  OH
City:  Mentor
Zip:  44060

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

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.

This is a great opportunity to join a well-established, global company that will invest in your career growth over the long term. STERIS wouldn’t be where it is today without our incredible, talented people. That’s why we share in our success together by rewarding you for your hard work. Hiring people who are in it for the long run with STERIS is our ultimate goal.

We offer a comprehensive benefits package, including:

  • Competitive pay
  • Training and coaching
  • Medical, vision, dental and life insurance
  • 401(k) with a company match
  • Paid vacation time and paid holidays
  • Tuition assistance
  • Opportunities for advancement

•    Define and participate in the development of projects to implement or improve manufacturing efficiency and ensure compliance during manufacturing and design transfer.
•    Plan, organize, prioritize the work of the maintenance technicians and document control coordinator. 
•    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.
•    Manage and direct activities associated with the development process for projects assigned to your area of responsibility including required validation testing, procedures and drawings.
•    Comply with all applicable cGMP, ISO and OSHA regulations.
•    Coordinate all facility maintenance activities. Manage and direct all Contractors to ensure adherence to guidelines.
•    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.
•    Prepare presentations with appropriate data and conclusions.
•    Support plant Continuous Improvement activities.
•    Maintain all manufacturing, QA, and facility equipment through calibrations, PM’s and general facility maintenance.
•    Establish production rates and cost for manufacturing through time studies.

Duties - cont'd
Education Degree
    Required Experience
    • Bachelor of Science (B.S.) Degree or higher in Engineering required, mechanical engineering preferred.
    • 4+ years engineering experience in a manufacturing environment, within a regulated industry.
    • Experience purchasing, implementing, validating and calibrating captial equipment.
    • Experience leading and directing technicians day to day work.
    • Knowledge of Design Controls, cGMPs, AutoCad and MS literacy preferred.
    • Statistical data base literacy desirable.


    What STERIS Offers:

    The opportunity to join a company that will invest in you for the long-term. STERIS couldn’t be where it is today without our incredible people. That’s why we share in our success together by rewarding you for your hard work. Hiring people who are in it for the long run with STERIS is our ultimate goal. We do this by providing competitive salaries, healthcare benefits, tuition assistance, paid-time off, holidays, matching 401(k), annual merit, and incentive plans.  Join us and help write our next chapter.


    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.

    Nearest Major Market: Cleveland
    Nearest Secondary Market: Akron

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