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 (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.
- Bachelor’s Degree in Engineering (Biomedical, Mechanical, Production, or Manufacturing Engineering preferred)
- Preferred knowledge of process validation, design for manufacturing, statistics and lean manufacturing principles
- Preferred knowledge of medical device quality standards ISO13485/FDA practices,GMP and similar regulated industry standards.
- Preferred knowledge of 3D Modeling software (Creo, Solid Works, etc)
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 sit, stand, walk, and communicate
**Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) of this employment position.**