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Systems Engineer for Software Medical Devices

Cambridge, Massachusetts

Sanofi, a global healthcare leader, discovers, develops, and distributes therapeutic solutions focused on patients' needs. With 12 locations in Massachusetts, many located within close proximity to Boston, you'll have easy access to public transportation, popular restaurants, some of the best education, and most of all the history.

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Responsibilities

Systems Engineer for Software Medical Devices

Our mission is to support the Sanofi business units by delivering differentiated services and solutions that help patients, physicians, care takers, payers as well as Sanofi to better take care of patients and provide an improved outcome to the healthcare system. Our services and solutions sit on top of our market leading technology platform which we continue to evolve.

We have recruited top talent in the field of Digital Health to help transform care in Diabetes and beyond in the areas of Drug+ apps. Our team recently has released an FDA certified class II medical device titration application, MyDoseCoach, and we are gearing up for other software applications across the diabetes journey.

For this team, we are seeking a software medical systems engineer for a next generation diabetes software application suite and platform.

Responsibilities:

  • Own the Design Control requirements for a range of class I and class II SaMD applications, containing cloud and mobile components.
  • Own the requirements of the interfaces to connected physical devices that provide data sources to the application
  • Enable and facilitate the verbal and written conversation between the Software Product Owners and the Software Architects, Engineers, Testers and Quality
  • Owns and bring in Design Control efficiency for SaMD development, keeping and maintaining compliant documentation.
  • Define, document and refine key algorithms within the application
  • Participate in the risk management and medical review to identify and define appropriate risk controls
  • Be an active contributor as part of our SaMD SCRUM teams to deliver towards the definition of done, focusing on the simplest solutions with the highest business value each sprint

Operational:

  • Complying with policies and processes and ensure they are communicated, understood, implemented, and maintained at all levels of the organization
  • Demonstrating excellent partnership and collaboration with other functions within the company to support common initiatives on medical devices
  • Demonstrating knowledge, skill and ability to model the Sanofi values and positively
  • Communicates the company visions, values, priorities and targets

Requirements:

  • BS degree in Electrical Engineering, Computer Science, Systems Engineering or equivalent
  • 7+ years of experience in design controls and FDA / ISO 13485 / IEC 62304 compliant software development
  • 3+ years of experience leading or participating in Agile / Scrum software development

Desired skills:

  • Experience in SaMD development and Life Cycle Management
  • Experience in project management or program management
  • Project management certifications
  • Excellent verbal and written communication skills.
  • Demonstrated initiative and analytical thinking style, able to comprehend complex problems and good problem solving skills
  • Self-motivated, innovative, and proactive. An individual who enjoys both the team environment as well as making an individual impact.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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