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.
Essential Job Functions:
- 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 engineer drawings/documents for manufacturing. Communicate with the other plants 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, 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 and FDA standards.
- Represent STERIS with machine tool, tooling, gage, and other outside suppliers.
- Other duties as assigned
Bachelor’s Degree in Industrial / Mechanical / or ElectricalEngineering and equivalent experience.
Advanced degree is a plus
- 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 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.
- Knowledge of Value Stream Mapping, JIT, Lean/Flow Manufacturing.
- 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.