Cincinnati, US
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 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.
Achieve, Cooperate, Care and Innovate are the values that we share and practice on a daily basis.
Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.
For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube
The Mechanical Engineer is 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 products.
YOUR ROLE:
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Perform mechanical design of components and assemblies for medical devices to include material selection, reliability testing, and other related duties.
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Provide technical support for product changes and new product manufacturing requirements. Develop and implement project plans from concept through feasibility, development, qualification and launch.
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Manage project plans to meet established schedule and cost targets.
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Prepare / approve mechanical development documentation, including product requirements, design specifications, and verification and validation protocols
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Prepare design drawings and layouts for product and component design changes.
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Responsible to ensure that all product development and design changes conform to the requirements of the Cincinnati Design Control procedures.
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Conduct / supervise verification and validation testing, and document testing results.
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Review operations engineering procedures and routings for the production. E.g. process qualification protocol’s and process procedures. Assist with operations training on manufacturing equipment and product.
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Evaluate and implement improvements to product designs and manufacturing processes.
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Develop, review and approve engineering change orders, considering improvements to quality, cost, customer requirements.
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Develop, document and lead product validations for product changes and tooling.
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Analyze, implement, and document design modifications required for improving product reliability.
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Develop estimates for capital requirements to support products and prepare CER’s as necessary.
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Participate in regulatory audits, FDA, ISO, UL, ETL etc. and resolve findings.
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Perform other duties that might be required as directed by the department management.
YOUR BACKGROUND:
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Minimum Bachelors degree in Mechanical Engineering
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Experience with computer aided design software i.e. Solidworks. (AutoCAD, Creo a plus)
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Ability to work with CAD data management software i.e. Solidworks PDM
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Experience with reliability testing methods and principles.
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The ability to work within the design control processes based upon the understanding of the ISO13485, FDA 21 CFR 820 “Design Control Guidance for Medical Device Manufacturers” and other relevant medical device ISO standards.
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Understanding and knowledge in the application of root cause analysis and structured problem solving.
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Ability to identify, analyze and implement improvements independently and to propose changes to existing methods, procedures, processes and/or products.
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Ability to effectively manage multiple open projects simultaneously. Use of project management skills throughout the project concept, feasibility, development, qualification and launch.
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Experience and proficient use with Microsoft Office products Word, Excel, and Power Point.
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Strong written and verbal communication skills.
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Experience in project management and the use of Microsoft Project a plus.
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Certification in Six Sigma (DFSS) a plus
We offer continued personal development. When you join Guerbet, you :
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Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,
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Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world,
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Are joining a company where we value diversity of talents coming from various horizon.
We # Innovate # Cooperate # Care #Achieve at Guerbet.
Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.
Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to careers@guerbet.com or you can also call this number +19843443717
Nearest Major Market: Cincinnati