Senior Mechanical Engineer

Guerbet; Cincinnati (OH); On-site; USD 90,000 - 120,000; Full time

Job summary

Guerbet is seeking an experienced Senior Mechanical Engineer to lead design and development of mechanical components and assemblies for medical devices in Cincinnati. You will drive reliability analyses, material selection, and verification/validation protocols while ensuring compliance with design controls and GMP practices.

You will collaborate with manufacturing to ensure production-feasible designs, support risk management including FMEA, and manage project plans from concept through launch,

Qualifications

• Bachelor's degree in Mechanical Engineering required.
• 4-7 years of relevant mechanical design experience required.
• 2+ years designing injection-molded components required.
• Medical device product or packaging development experience preferred.
• CAD experience with SolidWorks, AutoCAD, or Creo; SolidWorks PDM preferred.
• Knowledge of design controls (ISO 13485, FDA 21 CFR 820) preferred.
• Ability to identify, analyze, and implement process or product improvements.
• Proficient with MS Word, Excel, and PowerPoint; willingness to expand software skills.

Responsibilities

• Design, develop, and sustain mechanical components and assemblies for medical devices including material selection and reliability testing.
• Provide technical support for product changes and manufacturing requirements from concept to launch.
• Create and manage project plans to meet schedule and cost targets.
• Ensure development changes comply with Cincinnati Design Control procedures.
• Prepare and approve development documentation, drawings, specs, and verification/validation protocols.
• Collaborate with manufacturing to ensure production-feasible designs (machining, assembly, additive manufacturing).
• Support risk management activities including risk analysis and FMEA preparation.
• Perform or supervise verification and validation testing and document results.
• Review operations procedures, routings, designs, and ECOs for quality, cost, and customer impact.

Skills

Mechanical design

Reliability testing

Design controls

Process improvement

Documentation

Cross-functional collaboration

Education

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks

AutoCAD

Creo

SolidWorks PDM

Job description

We are looking for an experienced Senior 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.
• 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.