Senior Manufacturing Engineer

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.

Possess the ability to manage multiple complex projects with a high level of detail and accuracy
Ability to work hands on with critical equipment/systems
Adhere to Quality Management System to ensure meetring FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements,
driving quality throughout the organization
Troubleshoot mechanical/electrical/pneumatic equipment and processes and provide direction to maintenance staff for equipment fixes
Identify opportunities for process improvements and drive project work
Acts as a resource for all operational departments for equipment support and process upgrades
Perform validation and qualification activities on equipment and processes
Ensure new or modified asset information is properly transferred into Maintenance and Calibration systems
Ability to read and comprehend blueprints, specifications and sketches and develop/modify CAD drawings for facility, equipment, and
systems
Write/modify facilities equipment/systems and manufacturing equipment documents and procedures
Provide support to the calibration department in writing/performing calibration procedures

- 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 with
minimal supervision.
- Ability to remain calm and receptive in fast paced situations.

- Bachelors Degree in Engineering, preferrably Electrical Engineering
- Experience troubleshooting/programming PLCs, PLC interface configurations, and HMIs preferred

- 5+ years of Engineering experience, preferrably in medical device manufacturing

- Experience with Sterilization systems/equipment is a plus

- 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

**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) for this employment position.