Manufacturing Engineer

The 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 using statistics and root cause analysis tools.

Line Support
•    Provide general oversight and monitoring of machinery – including project coordination for maintenance, upgrades,and repair when needed
•    Help with troubleshooting problems within the manufacturing process
•    Assist with CAPA (corrective and preventative actions) to resolve production and customer issues using root cause analysis and then follow through with the implementation of corrective action
•    Assist with formal failure analysis and issue resolution activities to ensure preventative action is accomplished. 
•    Upon request, create written documents, test plans, and reports demonstrating technical rationale for associated decisions(s) (e.g., qualifications, risk assessments, and work instructions).
•    Provide hands-on troubleshooting to both manufacturing equipment and manufacturing processes.
•    Provide the 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. 
•    Conduct time studies
•    Cycle time reduction
•    Assist with cost-down initiatives on manufacturing lines.
•    Assist with 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.
•    Research root causes for defects; work with vendors and internal manufacturing to improve quality.

Capacity Improvement
•    Assess and monitor manufacturing capacity capabilities and reconcile with demand.  Propose capacity improvement recommendations accordingly.
•    Installation Qualification, Operational Qualification, and Performance Qualification
•    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.

Other
•    Prototype of assembly/manufacturing concepts and product design changes
•    Participate in Kaizen events
 

•    BS in Engineering, preferably Mechanical Engineering, Chemical Engineering, Electrical Engineering or Manufacturing Engineering.
•    Minimum of two (2) 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