Job Description

Overview

The primary purpose of this 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

• Define, identify, procure, and qualify new equipment for manufacturing processes and test methods
• Collaborate in a team to 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 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.

Qualifications

• Bachelor's degree in Engineering
• Minimum of 2 years of 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 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.
• Excellent 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.