Overview

The primary purpose of the Sr. Engineering Controls Specialist position is to provide technical support to Production and Manufacturing Engineering. In addition, drive process improvements to increase Manufacturing efficiency plus further develop manufacturing activities within the plant.

Responsibilities

• The troubleshooting of tooling/machinery equipment for production, testing and continuous improvement.
• Generation of technical documentation associated with equipment. (schematics/drawings/URS)
• The integration of machined components with off the shelf parts to complete the equipment. (Keeping spares to a minimum)
• The manufacture of components as per the supplied drawings, with emphasis on machining fits and tolerances.
• The integration of electrical components. (HMI/PLC/Loadcell/sensors etc)
• The integration of any pneumatic components into the equipment. (Cylinders/regulators etc)
• Integration of Safety components as part of in-house CE marking. This includes safety relays, safety interlock switches, safety sensors, etc.
• The programming and debugging of equipment PLC.
• Assisting New Product Introduction Team to introduce new equipment into manufacturing.
• Support installation and maintenance of the equipment.
• 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.
• Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.
• Adhere to company standards for equipment components.

Qualifications

• AS degree in relevant field; or experience of such kind and amount as to provide a comparable background.
• 2 years experience that relates directly to the above essential job functions/duties.
• Ability to use machine shop equipment (milling machines, lathes etc) is an advantage.
• Familiarity with 3D CAD package such as Creo/Solidworks is preferred.
• Knowledge of medical device quality standards/practices or similar regulated industry.
• Good communication and inter-personal skills.
• Proven problem-solving skills and High self-motivation.
• Good computer skills including knowledge of Microsoft® Office.
• Organizational and team building skills.

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 stand, walk, and communicate.

- Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA