Senior Consumables Mechanical Engineer - Medical Devices

Crosslinked; Cincinnati (OH); On-site; USD 110,000 - 150,000; Full time

Job summary

Guerbet in Cincinnati, OH is seeking a Sr. Consumables Mechanical Engineer to own the design and development of mechanical components and assemblies for medical devices and sterile consumables, including material selection and reliability testing.

You will lead verification, validation, and design-change activity, collaborate with manufacturing, and ensure compliance with ISO 13485, FDA 21 CFR 820, and related standards.

Qualifications

• Bachelor’s degree in Mechanical Engineering is required.
• 4–7 years of relevant mechanical engineering experience are required.
• 2+ years designing injection-molded components are required.
• Medical device, sterile product, and/or packaging development experience is preferred.
• CAD experience with SolidWorks, AutoCAD, or Creo; SolidWorks PDM is preferred.
• Knowledge of design controls, ISO 13485, FDA 21 CFR 820, and medical device standards is preferred.

Responsibilities

• Design, develop, and sustain mechanical components and assemblies for medical devices and sterile consumables, 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.

Skills

CAD experience

Project management

Reliability testing

Design controls

Education

Bachelor’s degree in Mechanical Engineering

Tools

SolidWorks

AutoCAD

Creo

SolidWorks PDM

Job description

Guerbet in Cincinnati, OH is seeking a Sr. Consumables Mechanical Engineer to own the design and development of mechanical components and assemblies for medical devices and sterile consumables, including material selection and reliability testing.

You will lead verification, validation, and design-change activity, collaborate with manufacturing, and ensure compliance with ISO 13485, FDA 21 CFR 820, and related standards.