Medline has an immediate opening for a Sterilization Engineer located in our Waukegan, IL facility. This position will be the technical advisor to Medline divisions, vendors and customers on issues related to sterilization of medical devices and pharmaceuticals. We are seeking a dynamic, hard-working professional with a desire to work for a fast-paced organization. In addition to exceptional leadership and analytical skills, you must have a “roll-up your sleeves” attitude. The challenging responsibilities of the position include:
Evaluation of processes and equipment used for sterilization and/or manufacture of sterile products.
Investigate and trouble shoot issues related to steam, ethylene oxide and radiation processes.
Product development input and support for sterilization of new products and sterilization methodologies.
Work with vendors on pre construction planning to communicate and assure implementation of Medline requirements for sterilization facilities. Assist with validation plans for new sterilization facilities.
Preparation of technical justification positions for regulatory agencies (such as 510k submissions), product bids and customers related to sterilization.
Communicate with laboratories, internal and external, on projects related to sterilization. Examples include bioburden testing, product sterility testing, radiation sterilization dosimetry, dose setting and audits and environmental testing.
International sterilization facility technical support which includes supporting sterilization teams in Asia and Europe.
Willing to work safely according to Medline and Federal safety rules and regulations in environments where hazardous chemical sterilizing agents may be encountered.
In return, Medline offers a business casual, entrepreneurial work environment with strong growth potential; a competitive compensation package; along with a complete benefits package including medical/dental/vision/life insurance; 401(k) with company match and much more! Qualifications include:
Bachelor of Science degree in a technical field. Mechanical engineering and/or Microbiology preferred
Experience in the medical device or pharmaceutical industry preferred
Ability to travel 25%-40% both domestically and internationally
Knowledge of AAMI/ISO sterilization standards a plus
Sterilization experience a plus
Proficient in Microsoft Word and Excel. MS Project a plus
Knowledge of FDA Quality System Regulations
Medline Industries, Inc. is an Equal Opportunity, Affirmative Action and Drug Free Employer. No agencies.
Medline Industries - 19 months ago
When health care supplies are on the line, Medline Industries goes toe-to-toe with the big guys. With more than 125,000 products, the...