Sr. Consumables Mechanical Engineer

Guerbet; Cincinnati (OH); On-site; USD 80,000 - 110,000; Full time

Job summary

Guerbet seeks an experienced Consumables Mechanical Engineer to design and develop mechanical components and assemblies for medical devices and sterile consumables, driving reliability and lifecycle engineering from concept through launch.

You will ensure compliance with design controls, prepare docs and specs, and collaborate with manufacturing to enable production-ready designs and robust validation protocols.

Qualifications

• Bachelor’s degree in Mechanical Engineering required.
• 4–7 years of relevant mechanical engineering experience.
• 2+ years designing injection-molded components.
• Medical device, sterile product, or packaging development preferred.
• CAD experience with SolidWorks, AutoCAD, or Creo; SolidWorks PDM preferred.
• Regulatory knowledge: ISO 13485, FDA 21 CFR 820 preferred.
• Ability to independently identify and implement improvements.

Responsibilities

• Design, develop, and sustain mechanical components and assemblies for medical devices and sterile consumables.
• Provide technical support for product changes and manufacturing requirements.
• Create and manage project plans to meet schedule and cost targets.
• Ensure compliance with Cincinnati Design Control procedures.
• Prepare mechanical development docs, drawings, specs, and verification protocols.
• Collaborate with manufacturing on feasible designs and AM considerations.
• Support risk management including risk analysis and FMEA.
• Lead product validations for changes and tooling.

Skills

Mechanical design

Reliability testing

Materials selection

Design for manufacturability

Project planning

Collaborative cross-functional work

Education

Bachelor’s degree in Mechanical Engineering

Tools

SolidWorks

AutoCAD

Creo

SolidWorks PDM

Job description

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 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.

Achieve, Cooperate, Care and Innovate are the values that we share and practice on a daily basis.

Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube

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.


• 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.

Reason to join US

Much more than a Competitive salary,

We offer continued personal development. When you join Guerbet, you :

• Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,


• Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world,


• Are joining a company where we value diversity of talents coming from various horizon.

We # Innovate # Cooperate # Care #Achieve at Guerbet.

Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.