Manufacturing Systems Engineer

2 weeks ago

Southington, Ohio, United States ICU Medical Full time

Position Overview

The Manufacturing Systems Engineer operates autonomously within established protocols pertinent to the specific role. This position requires a solid proficiency in various competencies relevant to manufacturing processes. Responsibilities include conducting preventive maintenance and executing repairs on intricate production machinery and systems (mechanical and electrical). The engineer will assess and propose enhancements to equipment aimed at boosting efficiency, capacity, and output quality. Conducting failure analyses on equipment (both preventive and reactive maintenance) is essential. The role also involves troubleshooting and diagnosing complex equipment issues. Technical documentation, including reports on equipment modifications and maintenance procedures, is a critical aspect of this position. The engineer will supervise and evaluate the work of junior technicians and typically reports to a Supervisor or Manager. The primary focus is to provide direct support for process equipment and assist production maintenance teams in complex troubleshooting and equipment enhancements. Additionally, the engineer will aid in assessing current processes and equipment, recommend and evaluate improvement options, and specify ongoing maintenance needs. There may be opportunities to guide maintenance personnel and coordinate activities with external contractors. Acting as a technical resource for maintenance mechanics and escalating concerns to supervisors when necessary is also part of the role. The engineer may take on a leadership position by mentoring less experienced mechanics and area engineers. Participation in the design and development of new equipment in collaboration with the Engineering team is expected. Occasional travel may be required for equipment assessments.

Key Responsibilities

· Ensure the successful execution of assigned maintenance tasks or process enhancements. Integrate cutting-edge technology with existing systems to optimize processes. Keep the Supervisor informed about project progress and technical challenges.

· Execute tasks and assignments from the supervisor, adhering to established timelines. Follow up on projects with minimal oversight. Actively participate in maintenance meetings and improvement discussions as a key contributor in the designated support area.

· Plan, coordinate, install, and conduct operational checkouts for equipment and processes within the assigned scope of responsibility.

· Perform maintenance, repairs, complex troubleshooting, redesign, and enhancements of mechanical, electrical, and PLC systems.

· Initiate miscellaneous purchase requisitions for materials, spare parts, equipment, and services as needed.

· Troubleshoot and assist in the repair of equipment and processes within the area of responsibility. Make accurate and concise decisions or recommendations based on assessments.

· Advise supervisors on appropriate timing for addressing issues and review spare parts, specifications, SOPs, and preventive maintenance for equipment and processes in the area of responsibility.

· Train other personnel in specific procedures, methods, and operations related to processes and equipment as directed.

· Present evaluated test data verbally, in writing, electronically, and through formal presentations to supervisors and/or management for further input.

· Conduct due diligence on problems and research potential solutions within existing cGMP, cGDP guidelines, SOPs, and plant policies, considering cost-effectiveness, ease of operation, and clean design.

· Maintain up-to-date knowledge of relevant cGMPs, cGDP, SOPs, and plant policies/rules/training. Promote safety practices and set an example for other employees.

· Serve as a technical resource for plant and corporate interactions as necessary.

· Provide line coverage during unexpected absences of maintenance mechanics when required.

· Perform other related duties as assigned or required.

· Overtime may be required or requested based on plant needs as directed by the supervisor.

Core Competencies

· Problem Solving: Assist and mentor peers in troubleshooting and problem-solving opportunities. Address chronic equipment issues using a systematic approach and share knowledge with others.

· Preventative Maintenance: Support others with complex repairs and share best practices. Address chronic issues to reduce mean time to repair through comprehensive equipment restoration.

· Collaboration: Foster a culture that encourages innovation and improvement suggestions from all mechanics. Manage complex interpersonal situations effectively to ensure seamless collaboration across the organization.

· Continuous Improvement: Participate in project teams or serve as an improvement champion, sharing knowledge with colleagues across all shifts.

· Principles of Operation: Assist others in understanding the operation of complex equipment and develop technical training and troubleshooting guides.

Knowledge, Skills & Qualifications

· This role demands a high level of resourcefulness, self-motivation, and the ability to work independently while overcoming obstacles and resolving issues. Strong decision-making skills are essential.

· Proficiency in interpreting engineering specifications and reading engineering drawings is required. A thorough understanding of basic mechanical and electrical principles is necessary for troubleshooting equipment and processes.

· Proficiency in MS Office, PLC troubleshooting, and mechanical systems is expected. Strong verbal communication and technical writing skills are essential.

· The ability to exercise diplomacy in leading and directing other employees is necessary. Flexibility in work schedule and the ability to work overtime, weekends, and adjust schedules on short notice is required to support plant operations.

· Must achieve Qualified Fellow Employee (QFE) status.

Minimum Qualifications, Education & Experience

· Candidates must be at least 18 years of age.

· A high school diploma is required; an associate degree from an accredited institution is preferred.

· A minimum of 6-10 years of experience with industrial mechanical, electrical, or similar systems is required.

· Skills or experience in welding, pipe fitting, sheet metal work, and/or hydraulic hose fabrication are preferred.

Physical Requirements and Work Environment

· The work environment may vary from clean rooms with specific gowning requirements to production areas that are open, potentially noisy, and involve moving equipment.

· Candidates must be able to lift a maximum of 50 lbs. unassisted and be capable of lifting and moving equipment/parts up to 600 lbs. with assistance.

· Travel is typically less than 5% of the time.

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