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 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.
- 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 vendors for discontinued or changed materials.
- Work with management to establish project timeliness, project justification, and budget forecasts.
- Act as resource for operational departments for materials, equipment and process upgrades.
- Work to transfer intra-Cook company products into operations.
- Work with vendors for discontinued or changed materials.
- Work with management to establish project timeliness, project justification, and budget forecasts.
- Act as resource for operational departments for materials, equipment and process upgrades.
- Work to transfer intra-Cook company products into operations.
- 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.
Qualifications
- Bachelor’s Degree in Engineering
- A degree in Mechanical, Electrical, Production, or Manufacturing Engineering preferred
- 2+ years of experience
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.
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