Overview

This is a Sr. level position requiring 5 years of subject matter expert CONTROLS experience in Large and Small production equipment (ex: Allen Bradley). The goal of this position is to drive process improvement and increase manufacturing efficiency.

Responsibilities

• Define, identify, procure, and qualify new equipment for manufacturing processes and test methods
• Design and optimize process and process equipment for large and small scale manufacturing.
• Execute methods needed for efficient and effective process and test method development (design for manufacturing/assembly, process validation, process capability, lean manufacturing, equipment selection and qualification, and specification development).
• Generation of technical documentation associated with equipment. (schematics/drawings/User Manuals)
• Hold equipment design review meetings to agree on feasible solutions.
• Manage Vendors for delivery of build components.
• The integration of machined components with off the shelf parts to complete the equipment. (Keeping spares to a minimum)
• Generation of the specification for any components required within the equipment, i.e. PLCs, Sensors, Pneumatic Actuators, and Servo Motors etc.
• 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 of new automation/control technologies for implementation into new and existing equipment.
• Provide technical support for the equipment build during build and debug of the equipment once complete.
• 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.

Qualifications

Requirements:

• Bachelors degree in Engineering required
• Minimum of 5 years’ relevant experience is required.
• Ability to use machine shop equipment (milling machines, lathes etc) is an advantage.
• Ability to use a 3D Cad package such as Creo/Solidworks is required.
• Knowledge of CE marking standards, 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 environment conditions.- Utilizes close visual acuity for working with computers and equipment.- Frequently required to sit, stand, walk, and communicate.

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