Sr. Consumables Mechanical Engineer

Role details

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 100 years, we continuously innovate to improve the diagnosis, prognosis and quality of life of patients.

Customer Centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice on a daily basis.

Working at Guerbet is not only being part of a multicultural team with nearly 3,000 people across more than 20 countries, but it is above all about playing a unique role in the future of medical imaging.

WHAT WE ARE LOOKING FOR

We are looking for an experienced 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.
• Project management experience, including Microsoft Project, 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.