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Job Title:  Manufacturing Engineer

Req ID:  21505
Job Category:  Manufacturing Operations
Country/Region:  US
State:  AL
City:  Montgomery
Zip:  36109

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

This position is accountable to define defining, document, validate, change, improve and maintain processes to manufacture components and assemblies within the Montgomery Facility.  This includes all current processes, as well as new product releases, and/or product transfers.

  • Lead and/or participate on project and improvement teams. Coordinate the efforts of engineers, technicians and other professionals of various disciplines/departments to design, develop, document and continuously improve product, equipment and processes. 
  • Plan, schedule, conduct and coordinate the design, validation, and initial prove-out of all processes for assigned projects.
  • Change, update and document changes required to ensure components are manufactured to current design requirements. While maintaining cost of components and assemblies at or below established targets.
  • Interpret engineering drawings/documents for manufacturing. Communicate with the other facilities as required, to support technology transfer. Coordinate with CNC Programmers, Tool & Die, Purchasing and any required subcontractors to produce components to meet project and schedule delivery dates. 
  • Create/coordinate Bills of Material (BOM), and other documents required to support manufacturing processes.  
  • Process/implement engineering changes and product documentation per established schedules.
  • Lead CAPA and continuous improvement projects. Participate in audits, investigations and tests. Evaluate internal and/or external manufacturing processes and technologies. Initiate and implement improvements to those processes. 
  • Support compliant process, failure investigations and material review boards.
  • Validate new processes and products. Develop flow charts, validation protocols. Perform DOE, DFMA, process capability studies and PFMEA as required. Initiate and implement strategies for reducing cost, improving quality and 
  • productivity by applying lean and six sigma methodologies. 
  • Document all processes using AS400 and applicable Standard Work formats. 
  • Specify, identify, and justify, and obtain approvals for purchasing capital equipment to support Montgomery manufacturing processes.
  • Perform root cause analyses for process failures, and implementing countermeasures to eliminate causes.
  • Evaluate processes to identify and eliminate wastes and improve quality and productivity.
  • Ensure that all processes and equipment comply with all applicable OSHA, ISO and FDA standards.
  • Represent STERIS with machine tool, tooling, gage, and other outside suppliers. 
  • Support new product development activities including reviewing documentation / prototypes from the Engineering team and suggesting improvements, participating in pre-production builds and ensuring results are communicated back to engineering. 
  • Represents manufacturing/operations on new product development project teams as needed
Education Degree
  • Bachelor's Degree
Required Experience
  • Minimum of 8 -10 years experience in engineering field with 4-5 years in a regulated manufacturing environment. 
  • Must have proven 3-4 years experience in 3-D design software (Pro-E preferred).  Excellent understanding of file management and documentation. Experience in component design, manufacturing, materials and testing of equipment is required. 
  • Experience in Medical Device development, design transfer, design for manufacturability (DFM), reliability and cost is preferred.
  • Excellent knowledge machining, machine tools, programming and tool design.  
  • Knowledge of sheet metal fabrication and welding is preferred. 
  • OSHA, ISO, FDA and Safety regulations knowledge is preferred.
  • Proficiency in advanced manufacturing processes and automation technologies desirable.
  • Excellent leadership skills.  Ability to interact with and leading cross-functional teams.
  • Must have a strong understanding of statistics, DOE and Six Sigma applications. In depth knowledge of machining equipment, processes and process control. Must have validation experience in developing and executing IQ, OQ and PQ and Minitab application. 
  • Excellent project management skills and experience in handling multiple projects, problem solving and trouble shooting skills in machining processes.
  • Proficiency in MS Word, Excel, Visio, MS project and Power point. 
  • Proficiency in MRP Systems.    


STERIS is a $3B, publicly traded (NYSE: STE) organization with approximately 12,000 associates worldwide and operates 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.

Nearest Major Market: Montgomery

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