Manufacturing Engineer - 2024-14942

Unclassified - Bloomington, IN

Full-time

Bloomington, IN

About the position

The Manufacturing Engineer at Cook Inc. is responsible for planning, directing, and coordinating manufacturing processes for medical device products. This role is crucial in supporting Operations to ensure that high-quality products are produced in a timely manner. The Manufacturing Engineer collaborates closely with Operations, Quality Assurance, and Regulatory Affairs teams to enhance existing product designs and processes. The goal is to increase throughput, reduce operational costs, and improve overall product quality. This position requires a proactive approach to problem-solving and innovation in manufacturing processes. In this role, the Manufacturing Engineer will work with Operations Managers and external vendors to develop methods and machines that enhance product capacity. They will also collaborate with Product Development Engineers to establish processes for new products, ensuring that these processes align with company standards and requirements. Additionally, the Manufacturing Engineer will engage with Operations, Accounting, and Global Product Managers to identify opportunities for increasing profit margins on current products that do not meet company expectations. Training relevant personnel on new processes is a key responsibility, as is documenting cost savings and writing/executing validation protocols. The Manufacturing Engineer must ensure that all projects adhere to design controls established by Quality System Procedures (QSPs) and provide support to the calibration department in writing and performing calibration procedures. They will also work with Quality Assurance and Product Development teams to verify and validate critical processes or products. Establishing project timelines and justifications in collaboration with management is essential, as is acting as a resource for operational departments regarding materials, equipment, and process upgrades. Continuous development and growth are encouraged, and the Manufacturing Engineer must maintain all training requirements for the position. Accurate documentation consistent with relevant regulations and Cook's Quality Management System is also a critical aspect of this role. The Manufacturing Engineer must interact effectively and professionally with colleagues at various levels of the global organization, adhere strictly to safety requirements, and maintain regular and punctual attendance while meeting company quality and quantity standards.

Responsibilities

• Work with Operations Managers and outside Vendors to create methods/machines to help with capacity of products.
• Collaborate with Product Development Engineers to develop processes for new products.
• Engage with Operations, Accounting, and Global Product Managers to increase profit margins of current products that do not meet company requirements.
• Train all relevant personnel on new processes.
• Document cost savings.
• Write and execute validation protocols.
• Ensure projects follow design controls established by QSPs (Quality System Procedures).
• Provide support to the calibration department in writing/performing calibration procedures.
• Work with Quality Assurance and Product Development to verify/validate critical processes or products.
• Collaborate with management to establish project timelines and project justification.
• Act as a resource for operational departments for materials, equipment, and process upgrades.
• Maintain all training requirements for the position while seeking out opportunities for continuous development and growth.
• Prepare and maintain accurate documentation consistent with the requirements of pertinent regulations and Cook's Quality Management System where applicable.
• Interact effectively and professionally with and for others throughout various levels of the global organization.
• Strictly adhere to safety requirements.
• Maintain regular and punctual attendance.
• Meet company quality and quantity standards.
• Demonstrate effective communication skills and the ability to work in collaborative and independent work situations with minimal supervision.
• Remain calm and receptive in fast-paced situations.

Requirements

• Bachelor's Degree in Engineering.
• A degree in Mechanical, Electrical, Production, or Manufacturing Engineering preferred.