Job Description

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.

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 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 withminimal 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- 5+ Manufacturing Engineering years experience, preferably in medical device

Physical Requirements:

• Works under general office environmental conditions. • Sitting for extended periods, utilizing close visual acuity for working with computers, equipment, etc.• Researches and designs using standard computer equipment• The employee is frequently required to stand; walk; use hands to grasp, feel or touch; reach with hands and arms; climb or balance; stoop; kneel; crouch; or crawl; and talk; or hear.• Moderate exposure to noise level in the work environment that is moderate to occasionally loud

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