Lead Manufacturing Engineer - Value Engineering

Overview

The 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 Manufacturing 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 manufacturing 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).
• Work with Quality Assurance and Product Development to verify/validate critical processes or products.
• Work with management to establish project timeliness, and a project business case.
• Act as 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.
• 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.

• Minimum Bachelor’s degree in an engineering discipline, preferably Master’s degree.
• Disciplines in Biomedical, Mechanical, or Chemical Engineering.
• Minimum 7 years of Experience in Industry.
• Manufacturing Engineering or Design/Post Market Engineering background.
• Medical Device experience.

• Experience with value-stream mapping.
• Experience with Lean and/or Six Sigma and corresponding certification.
• Experience with Kaizen/Continuous Improvement and corresponding certification.
• Experience in leading major cost savings efforts in manufacturing (via process and/or design changes).

• 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.