Electrical and Hardware Sustaining Engineer

We have a current opportunity for a Electrical and Hardware Sustaining Engineer on a permanent basis. The position will be based in Galway. For further information about this position please apply.

We are seeking a proactive and detail-oriented Electrical and Hardware Sustaining Engineer to join our global sustaining value engineering team. This role involves designing, developing, modifying, and evaluating components used in the medical device field. You will oversee multiple complex engineering projects with high business impact and work in a global cross-functional environment.

Key Responsibilities:

• Drive continuous improvement and value engineering initiatives on released hardware products.
• Perform electrical, electronic, and mechanical design maintenance due to component obsolescence or value engineering proposals, including testing and validation.
• Prevent and respond to production stoppages due to supplier, design, or quality-related matters.
• Write and coordinate the implementation of engineering change orders.
• Identify potential medical device hazards and maintain Risk Management files.
• Design test methods and engineering studies.
• Create, review, and execute engineering studies, characterization assessments, and verification test protocols/reports.
• Lead and execute experimental and feasibility tests.
• Support qualification of new products/processes/testing and ensure compliance with quality standards.
• Deliver medical device design documentation compliant with FDA design controls and good documentation practices.
• Conduct medical device safety testing and maintain product compliance with applicable standards and regulatory requirements.
• Investigate and resolve corrective and preventative actions using appropriate problem-solving techniques.

Qualifications:

• Bachelor's or master's degree in Electrical, Mechanical, or Biomedical Engineering.
• Minimum four years of electrical engineering experience in the aerospace or medical device industry.
• Experience in PCB evaluation regarding upgrades and obsolescence.
• Familiarity with FDA Quality System Regulations and CE Mark EU.
• Capacity and willingness to meet substantial documentary requirements in a regulated environment.
• Experience in medical device engineering, particularly sustaining engineering, is a plus.

Benefits:

• Attractive salary package with pension
• Excellent career progression opportunities
• Health Insurance & Life Assurance cover
• Educational assistance and Udemy Online Learning
• Active Sports and Social club