Senior Manufacturing Process Planner

Job Summary

The Senior Manufacturing Process Planner will play a key role in planning, directing, and coordinating manufacturing processes for medical device products at Cook Medical. This individual will work closely with Operations, Quality Assurance, and Regulatory Affairs to improve existing product designs and processes, ensuring a quality product is produced in a timely manner.

Key Responsibilities

• Independently produce, organize, and maintain documentation or systems critical to the engineering team or department.
• Run short-term, long-term, and/or system-focused projects, or complete significant tasks critical to projects.
• Troubleshoot manual and/or automated processes and systems.
• Troubleshoot design, process, testing, and/or documentation issues.
• Install, qualify, and validate equipment and processes in the production area to improve yield and/or reduce cycle time.
• SUPPORT INSTALLATION, CALIBRATION, QUALIFICATION, AND MAINTENANCE OF THE EQUIPMENT.
• Define, implement, and support preventive maintenance activities.
• Coordinate maintenance and facilities functions in asset management system.
• Assist with emergency and scheduled System Breach and Recover plan.
• Develop or revise documents and procedures such as Drawings, Work Instructions, and Standard Operating Procedures.
• The integration of machined components with off the shelf parts to complete the equipment. (Keeping spares to a minimum).
• The integration of electrical components. (HMI/PLC/Loadcell/sensors etc).
• The integration of any pneumatic components into the equipment. (Cylinders/regulators etc).
• The debugging of equipment PLC.
• Assisting New Product Introduction Team to introduce new equipment into manufacturing.
• Research and provide technical support of new automation/control technologies for implementation into new and existing equipment.
• Liaise and communicate with the other project team members.
• Ability to complete projects within specific timelines and meeting performance expectations.
• Drive the development and execution of experimentation and testing to enable process characterization, optimization, and troubleshooting of processes and equipment.
• Build prototypes, develop manufacturing processes, perform testing, and/or develop appropriate documentation based on area of focus within the engineering department.
• Use judgment and experience to independently accomplish project objectives.
• Maintain high knowledge level related to the team's focus and relevant company systems.
• Serve as a mentor, trainer, and resource to the team within area of expertise.
• Prioritize work based on assigned goals.
• Read, comprehend and follow product and packaging specifications and manufacturing instructions and drawings.
• Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
• Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.