Senior Mechanical Engineer - Medical Devices & Validation

Guerbet; Cincinnati (OH); On-site; USD 90,000 - 130,000; Full time

Job summary

Guerbet in Cincinnati is seeking a Sr. Mechanical Engineer to design, develop, and sustain mechanical components and assemblies for medical devices, with responsibility for life cycle engineering and reliability testing.

You will manage projects from concept through launch, ensure producible designs with manufacturing input, perform risk analyses and FMEA, prepare validation protocols, and ensure compliance with GMP and ISO 13485 in a regulated medical device environment.

Qualifications

• Bachelor’s degree in Mechanical Engineering is required.
• 4–7 years of relevant mechanical design engineering experience is required.
• 2+ years designing injection-molded components is required.
• CAD experience, preferably SolidWorks, AutoCAD, or Creo; SolidWorks PDM experience preferred.
• Knowledge of design controls, ISO 13485, and FDA 21 CFR 820 preferred.

Responsibilities

• Design, develop, and sustain mechanical components and assemblies for medical devices.
• 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 and additive manufacturing considerations.

Skills

Design & develop

Reliability testing

Project leadership

Collaboration with manufacturing

Microsoft Office

Education

Bachelor’s degree in Mechanical Engineering

Tools

SolidWorks

AutoCAD

Creo

Job description

Guerbet in Cincinnati is seeking a Sr. Mechanical Engineer to design, develop, and sustain mechanical components and assemblies for medical devices, with responsibility for life cycle engineering and reliability testing.

You will manage projects from concept through launch, ensure producible designs with manufacturing input, perform risk analyses and FMEA, prepare validation protocols, and ensure compliance with GMP and ISO 13485 in a regulated medical device environment.