Medical Device Sustaining Engineer

ICU Medical; Dublin (OH); On-site; USD 95,000 - 120,000; Full time

Job summary

ICU Medical is seeking a Sustaining Engineer to lead cross-functional projects that support ongoing manufacture, regulatory compliance, and supply of medical devices. The role liaises with Engineering, Quality, Regulatory Affairs, Supply Chain, Manufacturing, and suppliers to evaluate and document changes in product, components, materials, and packaging.

The position drives timely resolution of technical and supply-related challenges by developing risk-based solutions and coordinating

Qualifications

• Bachelor’s degree in engineering from an accredited college or university.
• Minimum 5 years in medical device industry or related experience.
• Experience supporting product changes, validation activities, and regulated manufacturing processes preferred.

Responsibilities

• Lead cross-functional projects supporting on-market products with clear ownership and timelines.
• Investigate issues and collaborate with R&D, Quality, Regulatory, Manufacturing, and Suppliers to implement solutions.
• Coordinate change management activities and documentation (ECOs, specs, drawings, plans).
• Support product lifecycle management including design updates and risk assessments.
• Coordinate verification, validation, and qualification activities for design and packaging changes.

Skills

Cross-functional collaboration

Regulatory compliance

Project leadership

Risk assessment

Documentation

Design controls

CAD software

Problem solving

Minitab

Microsoft Project

Quality systems

Education

Bachelor’s degree in engineering

Tools

SolidWorks

Microsoft Project

Minitab

Job description

ICU Medical is seeking a Sustaining Engineer to lead cross-functional projects that support ongoing manufacture, regulatory compliance, and supply of medical devices. The role liaises with Engineering, Quality, Regulatory Affairs, Supply Chain, Manufacturing, and suppliers to evaluate and document changes in product, components, materials, and packaging.

The position drives timely resolution of technical and supply-related challenges by developing risk-based solutions and coordinating