Principal Design Engineer Digital Technologies
Sanofi
- Cambridge, MA
- Permanent
- Full-time
- 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.
- 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.
- Knowledge of risk management and mitigation strategies in a regulated environment.
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