Senior Mechanical Engineer - Medical Consumables & Devices

Guerbet; Cincinnati (OH); On-site; USD 85,000 - 125,000; Full time

Job summary

Guerbet is seeking an experienced Senior Consumables Mechanical Engineer to design and develop mechanical components and assemblies for medical devices and sterile consumables. The role includes reliability analysis, life cycle engineering, and post-development support from concept through launch.

Responsibilities cover design, documentation, material selection, risk management, and collaboration with manufacturing to ensure production-feasible designs.

Qualifications

• Bachelor's degree in Mechanical Engineering is required.
• 4–7 years of mechanical engineering experience is required.
• 2+ years designing injection-m molded components is required.

Responsibilities

• Design, develop, and sustain mechanical components and assemblies for medical devices and sterile consumables.
• Provide technical support for product changes and manufacturing requirements from concept through launch.
• Create and manage project plans to meet schedule and cost targets.
• Ensure compliance with design controls and GMP requirements in medical device manufacturing.
• Prepare development documentation, drawings, specs, and verification/validation protocols.
• Collaborate with manufacturing to ensure production-feasible designs and tooling considerations.
• Support risk management activities, including risk analysis and FMEA preparation.
• Conduct or supervise verification and validation testing and document results.

Skills

SolidWorks

AutoCAD

Creo

Reliability testing

Design controls

ISO 13485 knowledge

FDA 21 CFR 820

Microsoft Office

Education

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks PDM

Job description

Guerbet is seeking an experienced Senior Consumables Mechanical Engineer to design and develop mechanical components and assemblies for medical devices and sterile consumables. The role includes reliability analysis, life cycle engineering, and post-development support from concept through launch.

Responsibilities cover design, documentation, material selection, risk management, and collaboration with manufacturing to ensure production-feasible designs.