Lead Manufacturing Engineer - Value Engineering

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. - 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.
• 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.

• 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. Preferred 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). 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.