Sustaining Engineer — Medical Devices & Change Management

Socket.dev; Dublin (OH); On-site; USD 90,000 - 130,000; Full time

Job summary

ICU Medical is seeking a Sustaining Engineer to lead cross-functional projects ensuring continuous supply, quality, and regulatory compliance for on-market medical devices. You will coordinate changes across R&D, Quality, Regulatory Affairs, Manufacturing, and suppliers to implement robust design and verification activities.

The role emphasizes risk-based decision making, document control, and collaboration with multiple sites to maintain uninterrupted supply chains and meet FDA and ISO

Qualifications

• Understanding FDA, cGMP, and design controls in medical devices.
• Experience with engineering change processes in regulated manufacturing.
• Knowledge of packaging validation and accelerated aging methodologies.

Responsibilities

• Lead cross-functional projects for on-market products with clear ownership and milestones.
• Coordinate engineering change activities and maintain documentation (ECOs, specs, drawings).
• Assess supplier changes and coordinate testing for resins, components, and packaging materials.
• Coordinate product verification, validation, and qualification activities for changes.
• Provide regular updates to management and stakeholders on timelines and risks.

Skills

Regulatory knowledge

Risk management

Minitab

CAD/ SolidWorks

Project planning

Education

Bachelor’s degree in engineering

Tools

SolidWorks

Microsoft Project

Job description

ICU Medical is seeking a Sustaining Engineer to lead cross-functional projects ensuring continuous supply, quality, and regulatory compliance for on-market medical devices. You will coordinate changes across R&D, Quality, Regulatory Affairs, Manufacturing, and suppliers to implement robust design and verification activities.

The role emphasizes risk-based decision making, document control, and collaboration with multiple sites to maintain uninterrupted supply chains and meet FDA and ISO