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
• 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
- Ability to remain calm and receptive in fast paced situations.
- Bachelor’s 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.