Sr. Mechanical Engineer

Crosslinked; Cincinnati (OH); On-site; USD 110,000 - 170,000; Full time

Job summary

Guerbet is seeking an experienced Sr. Mechanical Engineer in Cincinnati, OH, to lead design and development of mechanical components for medical devices.

You will handle life-cycle engineering, material selection, and reliability analyses from concept through validation. The role requires a BS in Mechanical Engineering and 4–7 years of relevant experience, including injection-molded components and design controls familiarity.

Qualifications

• 4–7 years of relevant mechanical design engineering experience.
• 2+ years designing injection-molded components.
• Knowledge of design controls, ISO 13485, FDA 21 CFR 820, and applicable medical device standards.
• Medical device product, and/or packaging development experience preferred.
• Proficient with Microsoft Word, Excel, and PowerPoint.

Responsibilities

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

Skills

Mechanical design

Education

Bachelor’s degree in Mechanical Engineering

Tools

SolidWorks

AutoCAD

Creo

SolidWorks PDM

Microsoft Project

Job description

Crosslinked

Jobs/Sr. Mechanical Engineer

One of 4,516 polymer and materials roles on Crosslinked, each read for materials, degree, visa and salary. See roles like this

GU

Sr. Mechanical Engineer

Guerbet

• Cincinnati, OH today verified 2 h ago

BS-level Product Development roles on Crosslinked list a median of $118k (197 that show pay). This posting does not list pay.

Design and sustain mechanical components and assemblies for medical devices, including material selection and reliability testing.

Why it is interesting.

Own full mechanical design lifecycle for medical devices, from material selection through FDA/ISO validation.

Might not be for you.

Mechanical design role, not materials R&D — materials work is limited to selection and reliability testing.

Generalist BS acceptableSenior hires only Realistic requirements

Adjacent materials role2+ years designing injection-molded components required; select appropriate materials based on properties, performance, and medical device application requirements

Seniority Senior

Work On-site

Type Full-time

Degree BS

Experience 4–7 yrs

Industry Medical devices

Role Product Development

Techniques reliability testing12 roles

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 Sr. Mechanical Engineer that will be responsible for the design and development of mechanical components & assemblies, and reliability analysis on materials developed for medical devices. The individual will have responsibility for full mechanical design, life cycle engineering and post development support for new and existing medical products.

YOUR ROLE

• Design, develop, and sustain mechanical components and assemblies for medical devices 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 design engineering experience required.
• 2+ years designing injection-molded components required.
• Medical device 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.

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Common questions

Where is the Sr. Mechanical Engineer role at Guerbet based?

This role is based in Cincinnati, OH.

What degree is required for the Sr. Mechanical Engineer role at Guerbet?

This role requires a BS.

How many years of experience does this Sr. Mechanical Engineer role require?

The posting calls for 4–7 years of relevant experience.

What techniques or methods are required for this Sr. Mechanical Engineer role?

reliability testing.