Engineer , Manufacturing

Position: Engineer 1, Manufacturing

Location: Indianapolis

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 (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.

Qualifications

• 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 ISO 13485/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

Additional Information

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.