Automation Specialist
1 week ago
Join a leading organization in the medical device manufacturing sector, known for its commitment to innovation and quality. Our client is a prominent contract manufacturer in the United States, engaged in significant projects for top healthcare providers globally.
Position Summary
The Automation Specialist will play a crucial role in:
- Designing and implementing semi-automated and fully automated systems to improve operator safety, enhance product quality, and boost operational efficiency.
- Contributing to the development of new products and optimizing existing machinery for integrated solutions.
- Collaborating with engineering teams and maintenance personnel to troubleshoot automation challenges and perform necessary repairs.
- Diagnosing and resolving issues in mechanical, electrical, and control systems, ensuring automated equipment is equipped with redundancy and backup protocols.
- Leading initiatives to implement process control solutions through automation.
- Setting ambitious project improvement targets and driving efforts to achieve these goals.
- Developing strategies for process control, communication, and optimization in partnership with manufacturing engineers.
- Working alongside engineering management and business development to create innovative solutions that surpass process KPIs.
- Conducting commissioning and startup activities, including the creation and execution of equipment validation protocols.
- Ensuring the delivery of identified value and adherence to project timelines.
- Designing automation systems using tools such as SolidWorks in collaboration with the engineering and management teams.
- Evaluating and coordinating with external vendors for the machining and fabrication of tooling and systems, overseeing progress for manufacturability and cost efficiency.
- Providing standards and specifications for devices utilized in assembly equipment, ensuring compliance with safety regulations and customer requirements.
- Enhancing production equipment and processes, including fixtures and jigs for assembly, to improve product quality, increase productivity, or reduce costs.
- Offering budgetary estimates and ROI analysis for the integration of automation and communication into current assembly systems.
- Identifying, justifying, implementing, and managing new manufacturing systems and equipment to enhance plant productivity.
- Training Manufacturing Engineers and Maintenance Technicians on PLCs, HMIs, and electrical/electronic troubleshooting fundamentals.
- Executing engineering and quality methodologies such as FEA, Tolerance Analysis, DOE, SPC, FMEA, Process Capability, and Root-Cause Analysis.
- Approaching process optimization and problem-solving with a systematic mindset.
- Managing CAPAs (Corrective and Preventive Actions) within their areas of responsibility.
- Defining, producing, and implementing process work instructions.
- Creating, reviewing, and approving engineering drawings, equipment layouts, and specifications.
- Performing additional duties as required.
The ideal candidate for the Automation Specialist role will possess:
- A Bachelor of Science degree in Manufacturing, Mechanical, Electrical, Electronics and Communications Engineering, or a related technical field with a focus on processing and medical device assembly.
- Working knowledge of ISO standards and relevant customer and regulatory requirements.
- 3-5 years of direct experience in a related field.
- Experience in operating and maintaining a classified Clean Room, including GMP procedures, HVAC, and Data Acquisition.
- Familiarity with medical device assembly, including strong knowledge of ISO 13485/ISO 14971 standards, SPC, TQM, GMPs, and lean manufacturing principles.
- Knowledge of automation and auxiliary equipment, including robotics, control systems, and material handling.
- Proficiency in robotics, vision systems, sensors, PLCs, and equipment technology integration.
- Experience in lean manufacturing and new product development or launch support.
- Strong knowledge of PLC and HMI programming across various brands.
- Excellent project management skills, including budgeting and cost control.
- Understanding of statistical methods and metals machining is preferred.
- Exceptional written and verbal communication skills.
- Proficiency in Microsoft Word and Excel.
- Demonstrated expertise in SolidWorks.
- Regular exposure to moving mechanical parts during job duties.
- Occasional exposure to fumes, airborne particles, toxic or caustic chemicals, electrical shock risks, and vibrations.
- Moderate noise levels in the work environment.
The Automation Specialist will receive:
- A competitive base salary.
- A comprehensive benefits package.
- The opportunity to work on a variety of exciting projects.
- A clear path for career advancement to managerial or high-level individual contributor roles.
- A supportive and engaging company culture.
- A dedicated and passionate team.
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