Our Purpose and Team:
The strategic vision of Sanofi’s Global Medical Device organization is to lead the industry in device-mediated therapies with the ambition to develop, industrialize and maintain best-in-class drug-delivery systems and connected medical devices that are user-centric, innovative, environmentally sustainable, and enhance the value of the drug, in order to help patients improve their quality of life by empowering them to take control of their disease. Our specific mission is to support the Sanofi business units and R&D by delivering differentiated technology solutions that support administration of drugs and vaccines to help patients, healthcare workers, caregivers, and payers address unmet needs and provide improved health outcomes. Our products and solutions sit on top of our market leading technology platforms which we continue to evolve.
We continue to recruit top talent in the industry to help transform care in the areas of drug delivery devices and stand-alone medical devices. Our teams have developed and released to market auto-injectors, pens, safety syringes, as well as connected medical device technologies. As we continue to expand our portfolio, we are seeking a dynamic and experienced dynamic leader to join our team as an Principal Design Engineer Digital Technologies.
About the Role
Principal Design Engineer Digital Technologies will be responsible for supporting the design, development, and implementation of connected medical device technologies and ensuring they meet the specific needs of the pharmaceutical and drug-device combination products. Collaborate with cross-functional teams, including software engineers, quality assurance, regulatory affairs, and product management, to drive product development and ensure alignment with industry requirements. Conduct and / or support risk assessments related to the design and functionality of connected technologies in devices and implement risk mitigation strategies as needed.
In addition, stay updated on emerging technologies and industry trends related to connected medical devices and incorporate them into product development strategies. Support the development of prototypes and conducting rigorous testing to validate the performance and safety of devices and DDCPs containing connected technologies. Support GDPU and GDPQ Design Control Process and closely work and interact with the European Standards Organization. Interact with GDPU senior leadership, key representatives from the core platforms and device manufacturing sites, Global Quality, GRA and other key functions in M&S organization.
Key Accountabilities:
This position has a very strong influence on the company strategic growth, topline sales and delivering novel therapies to a wide range of diseases. It is a global role, responsible for supporting the development and implementation of digital technologies in core Sanofi platforms (Safety Systems, Pens, Auto-injectors, LVD / OBDS), secondary packaging and selected drug device combination products.
In this role Principal Design Engineer Digital Technologies will be responsible for:
Supporting the design, development, and implementation of connected & digital medical device technologies and ensuring they meet the specific needs of the pharmaceutical and drug-device combination products.
Scouting connected technologies landscape to identify suitable options to support R&D and GBU portfolios.
Supporting Lifecycle Management (LCM) of commercial products that contain connected technologies.
This individual will collaborate with cross-functional teams, including software engineers, quality assurance, regulatory affairs, and product management, to drive product development and ensure alignment with industry requirements.
Principal Design Engineer Digital Technologies will conduct and / or support risk assessments related to the design and functionality of connected & digital technologies in devices and implement risk mitigation strategies as needed.
The incumbent will be responsible for staying updated on emerging technologies and industry trends related to connected medical devices and incorporate them into product development strategies. In addition, Principal Design Engineer Digital Technologies will support the development of prototypes and conducting rigorous testing to validate the performance and safety of devices and DDCPs containing connected technologies.
Principal Design Engineer Digital Technologies will support GDPU and GDPQ Design Control Process and closely work and interact with the European Standards Organization.
This individual will interact with GDPU senior leadership, key representatives from the core platforms and device manufacturing sites, Global Quality, GRA and other key functions in M&S organization.
In the future, the role may expand to the management of a small group of Design and Senior Design Engineers. In this expanded role, this incumbent will be responsible for defining and implementing a strategy for providing adequate skill sets to meet future needs of the development team. This includes actively directing, motivating, and developing individuals and their skills, so that the resource needs are met.
Basic Qualifications:
Bachelor’s or Master’s degree in engineering or a related field
8 years of work experience in the area of connected & digital medical device technologies or equivalent.
Proven experience in the development of connected & digital medical devices, preferably within the pharmaceutical and drug/device combination product industries.
Experience with project management and the ability to lead cross-functional teams.
Strong understanding of regulatory requirements, including FDA guidelines for medical devices.
Excellent problem-solving and analytical skills.
Proven experience in leadership, functional or disciplinary.
Preferred Qualifications:
- Knowledge of risk management and mitigation strategies in a regulated environment.
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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