Operations Biomedical Engineer-Dental- Rush, NY

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. Our dental segment, HuFriedyGroup, enables dental professionals to reduce risk, improve efficiencies, drive compliance, and enhance patient and staff safety. At HuFriedyGroup, we are committed to helping dental professionals perfect their craft and deliver the highest level of care to each patient.

The Role

 

The Operations Engineer works within our dental manufacturing operation(s) that focus on sterility assurance. In this role you will lead and document control over new and existing equipment, new and sustaining Engineering of products and processes. As you manage the implementation and maintenance of equipment, product, and processes, you will lead a wide variety of projects to ensure successful transition into manufacturing. These projects will include new equipment procurement and installation, new product launches, as well as equipment, product, and process 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.

What You Will Do

 

• Define and participate in the development of projects to implement or improve manufacturing efficiency and ensure compliance during manufacturing and design transfer.
• Identify resource needs and monitor project and department budgets.
• Act as liaison and maintain a close relationship with R&D, Quality, Marketing, and Manufacturing personnel to implement approved development and improvement projects.
• Manage / direct activities within the development process for assigned projects including required validation testing, procedures, and drawings.
• Comply with all applicable cGMP, ISO and OSHA regulations.
• Manage / direct all Contractors to ensure adherence to guidelines.
• Prepare and conduct formal program reviews for management.  
• Maintain a dynamic file on all projects to ensure projects are proceeding in accordance with regulatory requirements. 
• Prepare presentations with appropriate data and conclusions.

What You Will Also Do

 

• Support plant Continuous Improvement and LEAN activities.
• Perform maintenance and/or monitor maintenance/preventative maintenance activities.
• Establish production rates and cost for manufacturing through time studies.
• Other responsibilities as assigned by leadership.

What You Will Need to Be Successful

 

• Bachelor’s degree required, preferably in Biomedical Engineering, Chemical Engineering, or Biology.
• Minimum four (4) years engineering experience in a manufacturing environment, within a medical device and/or regulated industry.
• Experience purchasing, implementing, validating and calibrating capital equipment, product, and processes.
• Experience leading teams and / or cross functional projects
• Experience leading failure investigations both with product and processes, including root cause analysis and implementation of corrective actions.

Preferred:

 

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

What STERIS Will Offer You

 

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.

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Pay range for this opportunity is $67,060.00 - $90,279.00.

 

Minimum pay rates offered will comply with county/city minimums, if higher than range listed.  Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc.

 

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention.  WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 associates and Customers in more than 100 countries.

 

If you need assistance completing the application process, please call 1 (440) 392.7047