Senior Mechanical Engineer - Medical Devices Full Lifecycle

Crosslinked; Cincinnati (OH); On-site; USD 110,000 - 170,000; Full time

Job summary

Guerbet is seeking an experienced Sr. Mechanical Engineer in Cincinnati, OH, to lead design and development of mechanical components for medical devices.

You will handle life-cycle engineering, material selection, and reliability analyses from concept through validation. The role requires a BS in Mechanical Engineering and 4–7 years of relevant experience, including injection-molded components and design controls familiarity.

Qualifications

• 4–7 years of relevant mechanical design engineering experience.
• 2+ years designing injection-molded components.
• Knowledge of design controls, ISO 13485, FDA 21 CFR 820, and applicable medical device standards.
• Medical device product, and/or packaging development experience preferred.
• Proficient with Microsoft Word, Excel, and PowerPoint.

Responsibilities

• Design, develop, and sustain mechanical components and assemblies for medical devices, including material selection and reliability testing.
• Provide technical support for product changes, new manufacturing requirements, and project execution from concept through launch.
• Create and manage project plans to meet schedule and cost targets.
• Ensure product development and design changes comply with Cincinnati Design Control procedures.
• Prepare and approve mechanical development documentation, drawings, specifications, and verification/validation protocols.
• Collaborate with manufacturing to ensure production-feasible designs, including machining, assembly, and additive manufacturing considerations.
• Support risk management activities, including risk analysis and FMEA preparation.
• Conduct or supervise verification and validation testing and document results.

Skills

Mechanical design

Education

Bachelor’s degree in Mechanical Engineering

Tools

SolidWorks

AutoCAD

Creo

SolidWorks PDM

Microsoft Project

Job description

Guerbet is seeking an experienced Sr. Mechanical Engineer in Cincinnati, OH, to lead design and development of mechanical components for medical devices.

You will handle life-cycle engineering, material selection, and reliability analyses from concept through validation. The role requires a BS in Mechanical Engineering and 4–7 years of relevant experience, including injection-molded components and design controls familiarity.