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.
Responsibilities
- 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 therequirements of pertinent regulations and Cooks 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 withminimal supervision.- Ability to remain calm and receptive in fast paced situations.
Qualifications
Requirements: Minimum Bachelor 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.
