Senior Manufacturing Engineer

Overview

The Senior Manufacturing Engineer 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.

• 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 Management System where applicable.

• Bachelor’s Degree in Engineering
• 5+ years of Manufacturing Engineering experience, preferably in medical device

• Works under general office environmental conditions.
• Sitting for extended periods, 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.