Senior Mechanical Engineer

Role details

WHAT WE ARE LOOKING FOR

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

.

• 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.