Manufacturing Engineer 1

Cook Group; Bloomington (IN); On-site; USD 65,000 - 90,000; Full time

Job summary

Cook Group is seeking a Manufacturing Engineer to plan, direct, and coordinate manufacturing processes for medical device products. You will support operations with QA and Regulatory Affairs to improve product designs and processes, boost throughput, and reduce costs.

The role emphasizes collaboration with operations, product development, and global managers to ensure timely, quality production and adherence to design controls and safety requirements.

Qualifications

• Bachelor's Degree in Mechanical, Electrical, Production, or Manufacturing Engineering.
• Strong communication and collaboration skills across Ops, QA, Regulatory.
• Ability to write and execute validation protocols and maintain documentation.

Responsibilities

• Collaborate with Operations Managers and vendors to improve capacity and methods.
• Coordinate with Product Development Engineers to develop processes for new products.
• Work with Operations, Accounting, and Global Product Managers to improve margins on existing products.
• Train personnel on new processes and document cost savings.
• Write and execute validation protocols and ensure compliance with design controls.

Skills

Process improvement

Cross-functional collaboration

Documentation

Communication

Quality systems

Safety compliance

Education

Bachelor's Degree in Engineering

Job description

Overview

The Manufacturing Engineer 1 plans, directs, and coordinates manufacturing processes for medical device products, and supports Operations in a way to assure a quality product is produced in a timely manner. The Production Engineer works with Operations, Quality Assurance and Regulatory Affairs to improve existing product designs and processes to increase throughput, decrease operational costs, or improve quality.

Responsibilities

• Work with Operations Managers and outside Vendors to create methods/machines to help with capacity of products.
• Work with Product Development Engineers to develop processes for new products.
• Work with Operations, Accounting, and Global Product Managers to increase profit margins of current products which do not meet company requirements.
• Train all relevant personnel on new processes.
• Document cost savings.
• Write and execute validation protocols.
• Assure 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.
• Work with management to establish project timeliness, and project justification.
• Act as resource for operational departments for materials, equipment and process upgrades.
• Must 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 ManagementSystem where applicable.
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
• Must strictly adhere to safety requirements.
• Maintain regular and punctual attendance.
• Must maintain company quality and quantity standards.
• Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with minimal supervision.
• Ability to remain calm and receptive in fast paced situations.

Qualifications

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

Physical Requirements:

• Works under general office environmental conditions.
• Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.
• Frequently required to stand, walk, and communicate.

Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.

"Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position."