Senior Manufacturing Engineer

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 Senior Manufacturing Engineer will provide manufacturing engineering support to operations through line support, continuous improvement, capacity improvements and new product transfers. You will improve the overall efficiency of the manufacturing operation while optimizing human work factors, quality control, material flow, etc. by identifying areas for improvement through use of statistics and root cause analysis tools.

What You Will Do

 

Line Support:

 

• Provide general oversight and monitoring of manufacturing and laboratory machinery: project coordination for maintenance, upgrades, troubleshooting and repair. Provide hands-on trouble shooting to both manufacturing equipment and manufacturing processes.
• Identify and implement GMP (good manufacturing practices) that apply to specific production area(s).
• Lead/Own CAPA (corrective and preventative actions) to resolve production and customer issues using root cause analysis and then follow through with implementation of corrective action.
• Lead formal failure analysis and issue resolution activities to ensure preventative action is accomplished.
• Create written documents, test plans and reports that demonstrate technical rationale for associated decisions(s) (e.g., qualifications, risk assessments, and work instructions).
• Provide operations department with effective technical support to meet manufacturing quality and quantity objectives.

Continuous Improvement & Capacity Improvement

 

• Utilize project management skills to drive continuous improvement initiatives to optimize yield, quality, cycle time and/or ergonomics.
• Own and execute cost down initiatives on manufacturing lines.
• Initiate and lead lean transformations on manufacturing lines as well as within supporting areas.
• Identify process improvement opportunities and provide technical solutions via analysis and hands-on interaction with designated processes, including troubleshooting of manufacturing issues when they occur.
• Assess and monitor manufacturing capacity capabilities and reconcile with demand.  Propose capacity improvement recommendations accordingly.
• Specify tooling, fixtures and equipment required to meet manufacturing capacity requirements.
• Coordinate efforts associated with planning, procuring, installing and qualifying tooling, fixtures and equipment.

New Product Transfers

 

• Work with product development engineering to drive back lessons learned as new products are being developed.
• Evaluate and provide input to product development teams to help ensure the introduction of a capable and efficient operation.
• Create/evaluate and release process documentation for new processes.
• Specify tooling, fixtures and equipment required to meet manufacturing capacity requirements.
• Coordinate efforts associated with planning, procuring, installing, and qualifying tooling, fixtures and equipment.
• Train operations personnel on new processes.

What You Will Need to be Successful

 

 

• BS in Engineering (preferably Biomedical Engineering, Mechanical Engineering or Manufacturing Engineering).
• Minimum of 5 years of Manufacturing Engineering experience, within the medical device manufacturing industry.
• Familiarity with ISO 13485, FDA Design Control, CAPA, SCAR, and audit procedures.
• Experience in structured problem solving and use of statistical tools.
• Training and experience in Lean and Six Sigma, or equivalent.
• Experience in Design for Manufacturing, DFMEA, PFMEA, DOE, and Validations

 

Preferred Experience

 

• CAD experience is a plus, preferably SolidWorks.

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.<