US - Manufacturing Engineer-Sr

Manufacturing Engineer

Responsible for the development of manufacturing methods to produce sophisticated technology products. Works under the direction of the Manufacturing Engineering Manager, developing new processes, layout optimization
-supporting validation activities, ensuring manufacturing requirements, cost, quality, and timing expectations are met.

Responsibilities:

• Equipment installation and validation activities (URS, FDS, IQ, OQ, PQ, and VRA)
• Cleaning validations (IQ, OQ, PQ)
• Coordinate the arrangement of machines within plant facilities to ensure the most efficient and productive layout.
• Working on capital projects, including financial justifications, and monitoring spend
• Develops, implements, and maintains methods, operation sequences, and processes in the manufacture or fabrication of parts, components, sub-assemblies, and final assemblies.
• Estimates manufacturing cost, determines time standards, and makes recommendations for tooling and process requirements of new or existing product lines.
• Maintains records and reporting systems for coordination of manufacturing operations.
• Interface with Design Engineering, Quality Engineering, Production Supervision, Tool & Die, and Machine Maintenance with respect to manufacturing method, tooling, and equipment.
• Conduct investigations, identify, and implement corrective and preventative actions, and support the appropriate disposition of material by providing engineering inputs under general supervision in conjunction with the Quality group.
• Works with cross-functional teams to develop Process Maps, pFMEA, MSA, and/or other risk analysis tools
• Demonstrates courage in bringing forward new ideas and seeing them through to completion.
• Ability to make impactful PowerPoint presentations
• Performs other duties as assigned by the Manufacturing Engineering or Project Manager.

Education:

• BS in Engineering is required
• MS Engineering a plus

Experience:

• 3-4 years with a BS degree or Experience with equipment installation and validation activities (URS, FDS, IQ, OQ, PQ, and VRA).
• Experience with CNC machining and validations (IQ, OQ, PQ).
• Experience with SAP and or Windchill for production routers and bill of material /change notice set up.
• Experience with AutoCAD/Draftsight/NX or similar software
• Working knowledge of metal finishing processes, including bead blasting process
• GD&T knowledge and experience
• Experience/knowledge with process characterization, analysis, control and validation utilizing statistical tools (Six Sigma methodologies and experience)
• Materials experience/knowledge with manufacturing using (all or some):
  Titanium, Cobalt Chrome, Stainless Steels, medical grade plastics, etc.
• Process experience working on continuous improvement projects
• MS PowerPoint a must
• Medical Device industry experience is a plus

Competencies:

• Design experience with product, fixturing, gauging, tooling, etc.
• Has a strong Drive for Results and acts with appropriate sense of urgency.
• Respects and values differences; takes advantage of differences to optimize results.
• Demonstrates empathy and respect.