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Guerbet is a leader in medical imaging worldwide, offering a wide range of pharmaceutical products, medical devices, digital and AI solutions for diagnostic and interventional imaging, to improve the diagnosis and treatment of patients.

A pioneer since more than 90 years in the field of contrast media, Guerbet is continuously innovating with 9% of revenue dedicated to Research & Development and four centers in France, Israel and the United States.

Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €817 million in revenue in 2019 with a global workforce of over 2,800 employees.

Achieve, Cooperate, Care and Innovate are the values that Guerbet's employees share and practice every day. Working at Guerbet means playing a unique part in the future of medical imaging. Passionate about its business, the company strive day in, day out to combine performance, quality and sustainable development.

For more information about Guerbet, please go to www.guerbet.com  and follow Guerbet on Twitter @GuerbetGroup

 

Sr Mechanical Engineer - Based in Cincinnati

Description

 

Guerbet is a human-scale company that aims to become a new global leader in medical imaging. Pioneer in contrast media with 90 years' ​experience, Guerbet is the only pharmaceutical group dedicated to medical imaging worldwide, with a presence in almost 80 countries via a network of subsidiaries and distributors.

The company offers a comprehensive range of CT scan, Cath Lab, Magnetic Resonance Imaging (MRI) and Interventional Radiology and Theranostic (IRT) products, along with a range of injectors and related medical devices to improve patients'​ diagnosis, prognosis and quality of life.

Its total workforce is of 2,700 employeesAchieve, Cooperate, Care and Innovate are the values that Guerbet's employees share and practice every day. Passionate about its business, the company strive day in, day out to combine performance, quality and sustainable development.

Join us and play a unique part in the future of medical imaging.

General Summary

 

The Senior Mechanical Engineer is responsible for the design and development of mechanical designs 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 products.ducts.

Principal Duties and Responsibilities

1. Design and develop mechanical parts and assemblies for production released medical devices and new products.

2. Provide technical support for product changes and new product manufacturing requirements.

3. Manage project plans to meet established schedule and cost targets.

4. Prepare / approve mechanical development documentation, including product requirements, design specifications, and verification and validation protocols

5. Prepare design drawings and layouts for product and component design changes.

6. Responsible to ensure that product development and design changes conform to the requirements of Guerbet Design Control procedures.

7. Conduct / supervise verification and validation testing, and document testing results.

8. Develop procedures and routings for the production products. Assist with operations training on manufacturing equipment and product.

9. Evaluate and implement improvements to product designs and manufacturing processes.

10. Develop, review and approve engineering change orders, considering improvements to quality, cost, customer requirements.

11. Develop, document and lead product and/or process pilot runs and validations for product changes.

12. Develop estimates for capital requirements to support products and prepare CER’s as necessary.

13. Participate in regulatory audits, FDA, ISO, UL, ETL etc. and resolve findings.

14. Lead and/or support efforts for continuous improvements through the use Six Sigma methodology.

15. Analyze, implement, and document design modifications required for improving product reliability.

Knowledge, Skills and Abilities Required

1. Minimum Bachelor's degree in Engineering.

2. Prefered Master’s degree in Mechanical Engineering.

3. Minimum of 5 years demonstrated experience in design of complex mechatronic systems, ideally for electro-medical devices or in any other constrained industry (aerospace, aviation, transport)

4. Expertise in modeling with computer aided design software (Solidworks 2017 and higher): solid and surface modeling

5. Understanding of Product Data Management system (Solidworks PDM)

6. Experience with reliability testing methods and principles.

7. Experience with tolerance stack-up analysis, static FEA and fatigue analysis.

8. Knowledge of geometric dimensioning and tolerancing GD&T (ANSME Y14.5-2009)

9. Knowledge of design control processes following ISO13485 or FDA 21 CFR 820 “Design Control Guidance For Medical Device Manufacturers”.

10. Knowledge of EN60601-1 standard.

11. Experience in the application of root cause analysis and structured problem solving.

12. Experience with machined parts, injection molded plastic parts, and integration of electronic boards.

13. Ability to identify, analyze and implement improvements independently and to propose changes to existing methods, procedures, processes and/or products.

14. Ability to effectively manage multiple open projects simultaneously. Use of project management skills throughout the project concept, feasibility, development, qualification and launch.

15. Certification in Six Sigma (DFSS) a plus

16. Experience and proficient use with Microsoft Office products Word, Excel, and Power Point.

17. Experience with vendor management; purchasing, RFQs, Prototype fabrication/assembly services.

18. Strong written and verbal communication skills, and ability to present mechanical concepts and studies clearly.