Our client, is a leading medical device manufacturer and provides an exceptional work environment along with excellent benefits. We currently have an opportunity for a Process Automation Controls Engineer position in our Advanced Manufacturing Engineering team. This engineering position will be focused on both development of new assembly automation platforms and the direct line support of current process automation in the clean room manufacturing area. To support the automation development part of the position, the individual will perform projects associated with automation machine design, sourcing, contractor/integrator management, programming, commissioning, debugging, and validation. To support the sustaining engineering part of the position, the individual will provide line support for assembly automation including process and technology improvements to current automation equipment. This individual will play a key role in working with management to identify and quantify opportunities for expansion of automation equipment in the clean room operations.
The ideal candidate must be a self-motivated individual who possesses high initiative, excellent problem solving skills, a passion for assembly automation and manufacturing technology advancement, proficiency in vision, PLC, and robot programming, and a base understanding of GMP/QSR. Computer literacy including MS Word, Excel, Project, SolidWorks and a basic understanding of statistical analysis techniques is required. Bachelor’s degree in an engineering discipline required. Prior experience in the medical device or similar regulated industry a plus.
- Bachelor’s degree in an Engineering discipline
- A minimum of three years of experience as Automation or Controls Engineer
- Ability to communicate effectively at all levels of personnel
- Proficient with major software tools including MS Office, MS Project, SolidWorks, and statistical analysis software
- Proficient with PLC programming, HMI programming, and vision system programming
- Possess above average writing, analytical, and communication skills
- Experience with industrial networks and safety standards preferred.
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- Manage automation and equipment projects from conceptual design, capital expenditure approval, management of integration suppliers, factory/site acceptance, and validation and production release.
- Commission, program, and debug automated assembly machine with PLC and HMI technology.
- Development and documentation of all equipment requirements prior to sourcing and maintenance of project schedules and files
- Supports automation and advanced equipment on the production floor through Sustaining Engineering responsibilities for specific equipment
- Provides project leadership and supervision, including project team management, for assigned automation, equipment, and software projects.
- Responsible for validation activities on assigned projects including Installation Qualification, Operational Qualification, Software Qualification, and Performance Qualification.
- Identify, justify and implement technology and equipment upgrades, new product and process technologies, and process improvements utilizes improved technology.
- Commission, program, and debug vision inspection systems. Maintain vision inspection development lab to support prototyping of technology for new applications on the manufacturing floor.
- Commission, program and debug robotic systems for both new technology incorporation and replacement/upgrade of existing equipment.
- Apply Lean Manufacturing methodology to develop and/or improve manufacturing lines in accordance with throughput and quality targets.
- Participates in Kaizen events and drives continuing improvements in line efficiency through application of LEAN principles.
- Understand basic requirements of design control during product and/or process development projects.
- Understand quality system requirements of customers, FDA, QSR, and other regulatory agencies, and use quality tools to improve processes and products within those standards.
- Lead projects requiring cross-functional team participation to meet project goals, responsible for maintaining schedules, timeline, and deliverables.
- Possess technical writing, project management and fundamental problem-solving skills.
- Able to apply advanced mathematical concepts and statistical analysis.
- Provide technical training of equipment to operators, maintenance, and sustaining engineers.