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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 Project Manager - Based in Cincinnati

General Summary

The Project Manager has full responsibility for the planning, organization, technical interpretation, and cross-functional execution of assigned projects.  This includes supervisory responsibilities for a multidiscipline staff of engineers and technicians as well as coordination of the activities of a cross-functional team.

Principal Duties and Responsibilities
  1. Maintains complete cross-functional responsibility for assuring that all required elements of the project strategy are completed.  This includes elements from Marketing, Service, Manufacturing, Quality, Legal and Regulatory.  The Project leader does not usually complete the tasks, but is responsible for assuring that the team members from other disciplines are completing the identified tasks to successfully launch a product.  These responsibilities are carried through until Post Launch Assessment. This requires excellent communication and interpersonal skills.
  2. As a subset of the above responsibilities, leads multidisciplinary (mechanical, electrical, software) technical team in the development of medical products.
  3. Defines Product Requirements and Design Input Specification (DIS), building on marketing, customer support, quality insurance and regulatory affairs.
  4. Responsible for developing products under the structure of Liebel-Flarsheim Development Procedures and FDA guidelines.
  5. Supervises design verification studies (protocols, performance studies, endurance, ageing, …), and product validation (protocols and reports) including usability and Human Factor analysis.
  6. Coordinates, plans and ensures the follow-up of development projects, from concept to product launch on the market.
  7. Estimates resources and timing while creating project development plans.
  8. Responsible for establishing and managing the project budget.
  9. Manages risk management activities such as creating risk management plan, conducting risk analysis and FMEAs.
  10. Effectively leads team meetings and assures that proper communication regarding the project is appropriately distributed.
  11. Integrates efforts of other shared resources such as technical publications, document control, technicians, co-ops and drafters.
  12. Challenges electronic designs and reviews schematics proposals.
Education, Required Skills & Background
  1. Minimum Bachelor's degree in Engineering.
  2. Preferred Master’s degree in Electronics and Embedded Systems. 
  3. Minimum of 10 years experience in leading projects of development of medical products and processes, (ideally in imaging field), plus experience working in a multifunctional team environment.
  4. Demonstrated leadership abilities.
  5. Ability to create and maintain a Design History File (DHF) following FDA Design Control Principles (21 CFR Part 820) or ISO 13485 design controls.
  6. Knowledge of EN60601-1 and ISO14971 standards.
  7. Strong organizational and planning skills.
  8. Field experience of clinical environment and imaging procedures.
  9. Excellent interpersonal skills with demonstrated ability to work in a team environment with R&D, Manufacturing, Marketing, Sales, Service, Regulatory and Quality.
  10. Good oral and written communication skills along with ability to listen effectively to others.
  11. Ability to make clear reporting and project presentations with synthetic information and anticipation of project risks.
  12. Skills in problem identification and solving, including ability to negotiate and influence.
  13. Technical skills for Electronic Design and capability to review and challenge schematics proposals.
  14. Experience with IP assessment and FTO studies.