Senior Manufacturing Engineering Specialist - Cook Group

The Senior 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.

- Independently produce, organize, and maintain documentation or systems critical to the function of the engineering team or department.
- Run short-term, long-term, and/or system-focused projects, or complete significant tasks critical to projects.
- troubleshoot manual and/or automated processes and systems
- Troubleshoot design, process, testing, and/or documentation issues.
- Installs, qualifies, and validates equipment and processes in the production area to improve yield and/or reduce cycle time.
- Support installation, calibration, qualification, and maintenance of the equipment
- Define, implement, and support preventive maintenance activities.
- Coordinate maintenance and facilities functions in asset management system
- Assist with emergency and scheduled System Breach and Recover plan.
- Develop or revise documents and procedures such as Drawings, Work Instructions, and Standard Operating Procedures
- The integration of machined components with off the shelf parts to complete the equipment. (Keeping spares to a minimum)
- The integration of electrical components. (HMI/PLC/Loadcell/sensors etc)
- The integration of any pneumatic components into the equipment. (Cylinders/regulators etc)
- The debugging of equipment PLC.
- Assisting New Product Introduction Team to introduce new equipment into manufacturing.
- Research and provide technical support of new automation/control technologies for implementation into new and existing equipment.
- Liaise and communicate with the other project team members.
- Ability to complete projects within specific timelines and meeting performance expectations.
- Drive the development and execution of experimentation and testing to enable process characterization, optimization, and troubleshooting of processes and equipment
- Build prototypes, develop manufacturing processes, perform testing, and/or develop appropriate documentation based on area of focus within the engineering department.
- Use judgment and experience to independently accomplish project objectives.
- Maintain high knowledge level related to the team's focus and relevant company systems.
- Serve as a mentor, trainer, and resource to the team within area of expertise.
- Prioritize work based on assigned goals
- Read, comprehend and follow product and packaging specifications and manufacturing instructions and drawings.
- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.

- AS degree in relevant field; or experience of such kind and amount as to provide a comparable background.
- 5+ years experience that relates directly to the above essential job functions/duties.
- Knowledge of medical device quality standards/practices or similar regulated industry.
- Ability to use machine shop equipment (milling machines, lathes etc) is an advantage.
- Familiarity with 3D Cad package such as Creo/Solidworks is preferred.
- Experience working independently and with minimal supervision.
- Working knowledge of Microsoft Office Software (ie: Word, Excel).

- 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.

- Personal protective equipment including safety glasses, lab coat and gloves required in some areas associated with this position.
 - Sitting for extended periods, utilizes close visual acuity for working with computers, etc.
 - Works under general office environmental conditions.
 - Moderate exposure to noise level in the work environment that is moderate to occasionally loud.
 - Occasionally lifts and/or moves up to 50 pounds
 - Frequently required to stand, walk, use hands to grasp, carry, feel or touch; reach with hands and arms; talk and communicate.