Senior Consumables Mechanical Engineer

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

We are looking for an experienced Senior Consumables Mechanical Engineer that will be responsible for the design and development of mechanical components & assemblies, and reliability analysis on materials developed for medical devices and sterile consumables. The individual will have responsibility for full mechanical design, life cycle engineering and post development support for new and existing sterile medical consumables products.

YOUR ROLE

• 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.
• Select appropriate materials based on properties, performance, and medical device application requirements.
• 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.
• Review operations engineering procedures, routings, product designs, and engineering change orders for quality, cost, and customer-impact improvements.
• Develop, document, and lead product validations for product changes and tooling.
• Analyze, implement, and document design modifications to improve product reliability.
• Estimate capital requirements and prepare CERs as needed.
• Participate in regulatory audits, including FDA, ISO, UL, and ETL, and support resolution of findings.
• Follow applicable SOPs and GMP requirements in a medical device manufacturing and distribution environment.
• Work safely in accordance with regulations, standards, and procedures; report unsafe conditions and safety or environmental incidents immediately.
• Complete all required company and role-specific training by assigned deadlines.

YOUR BACKGROUND

• Bachelor's degree in Mechanical Engineering required.
• 4-7 years of relevant mechanical engineering experience required.
• 2+ years designing injection-molded components required.
• Medical device, sterile product, and/or packaging development experience preferred.
• CAD experience, preferably SolidWorks, AutoCAD, or Creo; SolidWorks PDM experience preferred.
• Reliability testing experience preferred.
• Knowledge of design controls, ISO 13485, FDA 21 CFR 820, and applicable medical device standards preferred.
• Ability to independently identify, analyze, and implement process, product, or procedural improvements.
• Proficient with Microsoft Word, Excel, and PowerPoint; willing to expand software skills as needed.