Mechanical Engineer

6 days ago

Cincinnati, Ohio, United States Laboratoire Guerbet Full time
About the Role

We are seeking a highly skilled Mechanical Engineer to join our team at Laboratoire Guerbet. As a Mechanical Engineer, you will be responsible for the design and development of mechanical components and assemblies for medical devices.

Key Responsibilities
  • Design and develop mechanical components and assemblies for medical devices, including material selection and reliability testing.
  • Provide technical support for product changes and new product manufacturing requirements.
  • Develop and implement project plans from concept through feasibility, development, qualification, and launch.
  • Manage project plans to meet established schedule and cost targets.
  • Prepare and approve mechanical development documentation, including product requirements, design specifications, and verification and validation protocols.
  • Prepare design drawings and layouts for product and component design changes.
  • Ensure that all product development and design changes conform to the requirements of the design control procedures.
  • Conduct and supervise verification and validation testing, and document testing results.
  • Review operations engineering procedures and routings for the production, including process qualification protocols and process procedures.
  • Assist with operations training on manufacturing equipment and product.
  • Evaluate and implement improvements to product designs and manufacturing processes.
  • Develop, review, and approve engineering change orders, considering improvements to quality, cost, and customer requirements.
  • Develop, document, and lead product validations for product changes and tooling.
  • Analyze, implement, and document design modifications required for improving product reliability.
  • Develop estimates for capital requirements to support products and prepare capital expenditure reports as necessary.
  • Participate in regulatory audits, including FDA, ISO, UL, and ETL, and resolve findings.
Requirements
  • Minimum Bachelor's degree in Mechanical Engineering.
  • Experience with computer-aided design software, including Solidworks.
  • Ability to work with CAD data management software, including Solidworks PDM.
  • Experience with reliability testing methods and principles.
  • Understanding and knowledge of the design control processes based on the ISO 13485 standard and other relevant medical device ISO standards.
  • Ability to identify, analyze, and implement improvements independently and to propose changes to existing methods, procedures, processes, and products.
  • Ability to effectively manage multiple open projects simultaneously, using project management skills throughout the project concept, feasibility, development, qualification, and launch.
  • Experience and proficient use of Microsoft Office products, including Word, Excel, and PowerPoint.
  • Strong written and verbal communication skills.
  • Experience in project management and the use of Microsoft Project is a plus.
  • Certification in Six Sigma (DFSS) is a plus.
About Laboratoire Guerbet

Laboratoire Guerbet is a global leader in medical imaging, offering a comprehensive portfolio of pharmaceuticals, medical devices, digital, and AI solutions for diagnostic and interventional imaging. We are committed to innovation, cooperation, care, and achievement, and we value diversity of talents from various horizons.

We are an equal opportunity employer and believe that no individual should be discriminated against because of their differences, including age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to any protected characteristic.

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