E&I Instrumentation

Company Overview:

Our client, a leading Medical Device company based in Galway, is dedicated to delivering high-quality medical solutions that improve patient outcomes. The company is committed to innovation and excellence, and they are seeking a talented E&I Instrumentation Engineer to join their growing team. The successful candidate will play a critical role in maintaining and enhancing the electrical and instrumentation systems used in the production of life-saving medical devices.

Position Overview:

As an E&I Instrumentation Engineer, you will be responsible for the maintenance, troubleshooting, and optimization of electrical and instrumentation systems within a highly regulated environment. You will work closely with cross-functional teams to ensure that all instrumentation systems are operating efficiently, reliably, and in compliance with regulatory standards. This role requires a strong background in electrical and instrumentation engineering, with experience in the medical device or regulated industries.

Key Responsibilities:

• Instrumentation Maintenance: Maintain and troubleshoot instrumentation systems (e.g., sensors, actuators, control systems) to ensure optimal functionality and performance.
• System Calibration: Perform calibration, validation, and qualification of instrumentation and electrical systems in accordance with FDA, ISO, and other regulatory standards.
• Compliance & Documentation: Ensure all activities comply with industry standards and regulations (e.g., ISO 13485, FDA 21 CFR Part 820). Maintain accurate records of maintenance activities, calibration data, and system changes.
• Project Support: Support new equipment installations, upgrades, and system modifications. Provide technical support for the design, testing, and validation of new instrumentation systems.
• Root Cause Analysis: Perform root cause analysis (RCA) for instrumentation-related issues and implement corrective and preventive actions (CAPA).
• Collaboration: Work with manufacturing, quality, and automation teams to ensure seamless integration and operation of electrical and instrumentation systems.
• Continuous Improvement: Identify opportunities for process improvements and efficiency gains in electrical and instrumentation systems.
• Training & Support: Provide training and technical support to operations and maintenance personnel on instrumentation systems and procedures.

Qualifications & Experience:

• Bachelor's degree in Electrical Engineering, Instrumentation, Automation, or a related field.
• 3+ years of experience in an instrumentation engineering role, ideally within the medical device or regulated industries (pharmaceutical, biotechnology, etc.).
• Solid understanding of electrical systems, control systems, and instrumentation (e.g., PLCs, SCADA, DCS, sensors, actuators, etc.).
• Experience with GxP environments and regulatory compliance (FDA, ISO, etc.).
• Knowledge of control system architectures, analog and digital signals, and instrumentation design.
• Proficient in AutoCAD, PLC programming, LabVIEW, or other relevant software tools.
• Strong troubleshooting and analytical skills with a proactive approach to problem-solving.
• Excellent written and verbal communication skills.

Desirable Skills:

• Experience with SCADA or DCS systems.
• Project management experience in regulated industries.
• Familiarity with Risk Management processes (e.g., FMEA).
• Six Sigma or Lean Manufacturing experience.
• Certified Automation Professional (CAP) or similar certifications.