Job 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

Provide Manufacturing Engineering support to Operations through line support, continuous improvement, capacity improvements and new product transfers.  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. 

Duties

Line Support 

• Provide general oversight and monitoring of machinery – including project coordination for maintenance, upgrades, and repair when needed
• Help with troubleshooting of problems within the manufacturing process
• Identify and implement GMP (good manufacturing practices) that apply to specific production area(s).
• Provide training as needed to ensure that the production team understands and follows GMP.
• Lead/own CAPA (corrective and preventative actions) to resolve production and customer issues.
• Lead formal failure analysis and issue resolution activities to ensure preventative action is accomplished.
• Provide work direction to Product or Process technicians as required.
• Create written documents, test plans and reports that demonstrate technical rationale for associated decisions(s) (e.g. qualifications, risk assessments, and work instructions).
• Provide hands-on manufacturing equipment and process trouble shooting.
• Provide operations department with effective technical support to meet manufacturing quality and quantity objectives.

Continuous 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.
  

Capacity Improvement

• 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.
  

Education Degree

• Bachelor's Degree in Engineering General

Required Experience

• Minimum of 5 years of Manufacturing Engineering experience, preferably within the medical device manufacturing industry.
• CAD experience is a plus, preferably SolidWorks
• 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

• Prefer BS in Mechanical Engineering or Manufacturing Engineering.
• Prefer experience within the medical device manufacturing industry.
• Prefer SolidWorks

#LI-BN1

Pay range for this opportunity is $84,750.00 - $118,650.00. This position is eligible for [BONUS PARTICIPATION] OR a [INSERT COMMISSION RATE RANGE, IF APPLICABLE] commission.

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.

Employees (and their families) may enroll in our company-sponsored medical, dental, vision, flexible spending, health savings account, voluntary benefits, supplemental life/AD&D plans and the company’s 401k plan. Employees are covered by an employee assistance program (also available to household members) and long-term disability. Full-Time Employees are also eligible for short-term disability.  Full-time Employees will also receive Paid Time Off (PTO) based on years of service and paid Holidays. Part-time employees working 20 or more hours receive a pro-ration of the full-time PTO allocation and paid Holidays based on their standard hourly work week. Full-Time employees are eligible for four weeks of paid parental leave. Part-time employees also receive paid parental leave, pro-rated based on their standard hourly work week.

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. 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.

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