Process Engineer III - Controls Engineer

Responsibilities

• Collaborates with quality and operations to determine and develop needed materials and/or parts specifications.
• Troubleshoots equipment and processes through physical inspection/diagnosing of parts.
• Orders replacement parts as needed.
• Revises equipment and part drawings using CAD software.
• Captures Engineering Change Notices for design changes, including materials and process changes (no managerial oversight).
• Coordinates Engineering Change Notices for design changes, including materials and process changes (no managerial oversight).
• Equipment validations including IQ OQ and PQ.
• Maintains and assists in development of PLC controlled processes.
• Evaluates and implements appropriate parameters for OEM equipment software.
• Led tasks or sub-projects within major product and process improvement initiatives.
• Provides technical support when dealing with suppliers of key components and equipment.
• Provides engineering support for new equipment start-up, debug and process validation.
• As required, develops, and conducts process evaluations and validations under guidance of senior engineers and quality engineering.
• Incorporates best practices in the creation and improving of Operations documentation.
• Captures product and packaging distribution and shelf-life tests.
• Assists in audit deliverables and/or CAPA investigations and deliverables as assigned by management.
• Successful implementation of new products and processes.
• Reduction of manufacturing errors and improvement of yields and cycle times.
• Successful completion of audits.
• Provide knowledge and feedback to the production team for the successful implementation of new processes or equipment.
• Addressing supplier continuity issues to prevent product run-out.
• Continuous Process Improvement.

Qualifications

• Master’s degree with 2-4 years of equivalent experience, or bachelor’s degree with 4-6 years of equivalent experience.
• Degree in Engineering (Electrical, Mechanical, Computer, Chemical).
• Data-Driven Problem Solving: Demonstrated understanding of problem-solving tools including; root cause analysis (5-why, fishbone) and Statistical process control (SPC), etc.
• Process Optimization / Lean Mfg.: Demonstrated execution of lean principles, cycle time / throughput improvement, yield improvement, workflow optimization, etc.
• Cross-Functional Collaboration: ability to work cross-functionally with operators, quality, regulatory and management teams; train operators and implement new processes, etc.
• Preferred Experience: Medical Device experience or experience working in a regulated environment.
• Experience designing, developing and implementing PLC DCS and SCADA systems.
• Experience creating and maintaining control logic, function blocks, and HMI interfaces.
• Experience specifying sensors, actuators, drives, and control hardware.
• Data flow analysis.